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1.
Gut and Liver ; : 92-99, 2023.
Artigo em Inglês | WPRIM | ID: wpr-966874

RESUMO

Background/Aims@#Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough in healthy subjects. @*Methods@#In a randomized, open-label, single-dose, balanced incomplete block crossover study, 24 healthy male volunteers were enrolled and randomized to receive oral tegoprazan (50, 100, or 200 mg) or dexlansoprazole (60 mg) during each of two administration periods, separated by a 7- to 10-day washout period. Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation. @*Results@#All 24 subjects completed the study. Average maximum plasma concentration, area under the plasma concentration–time curve, and mean time with gastric pH >4 and pH >6 for tegoprazan demonstrated dose-dependent incremental increases. All the tegoprazan groups reached mean pH ≥4 within 2 hours, whereas the dexlansoprazole group required 7 hours after drug administration. Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole. Moreover, the dexlansoprazole group presented a comparable acid-suppressive effect with the tegoprazan groups 12 hours after dosing. @*Conclusions@#All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group.

2.
Journal of Veterinary Science ; : e27-2023.
Artigo em Inglês | WPRIM | ID: wpr-977128

RESUMO

Background@#The relationships between the postpartum subacute ruminal acidosis (SARA) occurrence and predicted bacterial functions during the periparturient period are still not clear in Holstein cows. @*Objectives@#The present study was performed to investigate the alterations of rumen fermentation, bacterial community structure, and predicted bacterial functional pathways in Holstein cows. @*Methods@#Holstein cows were divided into the SARA (n = 6) or non-SARA (n = 4) groups, depending on whether they developed SARA during the first 2 weeks after parturition.Reticulo-ruminal pH was measured continuously during the study period. Reticulo-ruminal fluid samples were collected 3 weeks prepartum, and 2 and 6 weeks postpartum, and blood samples were collected 3 weeks before, 0, 2, 4 and 6 weeks postpartum. @*Results@#The postpartum decline in 7-day mean reticulo-ruminal pH was more severe and longer-lasting in the SARA group compared with the non-SARA group. Changes in predicted functional pathways were identified in the SARA group. A significant upregulation of pathway “PWY-6383” associated with Mycobacteriaceae species was identified at 3 weeks after parturition in the SARA group. Significantly identified pathways involved in denitrification (DENITRIFICATION-PWY and PWY-7084), detoxification of reactive oxygen and nitrogen species (PWY1G-0), and starch degradation (PWY-622) in the SARA group were downregulated. @*Conclusions@#The postpartum SARA occurrence is likely related to the predicted functions of rumen bacterial community rather than the alterations of rumen fermentation or fluid bacterial community structure. Therefore, our result suggests the underlying mechanisms, namely functional adaptation of bacterial community, causing postpartum SARA in Holstein cows during the periparturient period.

3.
Archives of Aesthetic Plastic Surgery ; : 183-189, 2023.
Artigo em Inglês | WPRIM | ID: wpr-999498

RESUMO

Background@#Ultrasonic devices have potential advantages over electrocautery surgical scalpels for muscle dissection, as they eliminate the risk of muscle contraction caused by electric currents. In this study, we investigated the outcomes of using both device types in subpectoral dissection for breast reconstruction. @*Methods@#In this retrospective single-center study, we examined the electronic medical records of female patients with non-recurrent breast cancer who underwent breast reconstruction. The patients were treated with either Harmonic Focus+ Shears (HFS) or a Bovie electrocautery scalpel (BES) between January 2015 and April 2020. The primary clinical outcomes evaluated were total drainage volume, time to drainage tube removal, and operation time. To control for confounding, outcomes were stratified based on the type of tissue expander used—either Mentor or Natrelle. @*Results@#The study included 303 patients; 155 (51.2%) were treated with HFS (mean age, 45.28±7.38 years) and 148 (48.8%) with BES (mean age, 44.41±9.37 years). Within each expander type, the frequency of drainage exceeding 30 cc per day after 21 postoperative days showed no statistical difference between the HFS and BES devices. The operation time was shorter for HFS in both the Mentor (85.13±19.81 minutes vs. 109.56±21.66 minutes, P<0.001) and Natrelle (88.09±20.64 minutes vs. 99.88±22.66, P<0.001) groups. @*Conclusions@#When controlling for the type of tissue expander as a confounding factor, HFS was associated with reduced operation time. Furthermore, it demonstrated superior clinical effectiveness compared to BES regarding operator convenience.

4.
Journal of the Korean Society of Emergency Medicine ; : 314-321, 2022.
Artigo em Coreano | WPRIM | ID: wpr-938353

RESUMO

Objective@#This study compared the treatment results of emergency department (ED) patients presenting with gingival bleeding, who were given dental consultations with those who were not. Also, the study compared patients presenting with gingival bleeding based on the period of availability of the dental consultation in the ED. @*Methods@#This was a retrospective study of patients with gingival bleeding visiting the ED from January 2011 to April 2020. The demographic data of patients, past medical history, etiology of bleeding, vital signs, lab findings, treatment methods, and disposition were analyzed. @*Results@#The mean level of hemoglobin was 13.3 g/dL in the group to whom dental consultation was made available, and 11.7 g/dL in the group not given dental consultation, which was a significant difference (P=0.010). Vitamin K injections were given to 1.9% of the former group and 6.2% of the latter group (P=0.049). Suturing was done in 14% of the former group and 1.2% of the latter (P<0.001). There were no significant differences between the two groups regarding admission to the ward or revisits to the ED. @*Conclusion@#Emergency physicians carried out conservative treatments for patients with gingival bleeding when dental consultation was unavailable. No differences in the treatment results were observed based on the length of time the dental consultation was made available.

5.
Journal of Veterinary Science ; : e34-2021.
Artigo em Inglês | WPRIM | ID: wpr-893754

RESUMO

Anti-lipopolysaccharide (LPS) antibody administration has the potential benefits of neutralizing and consequently controlling rumen-derived LPS during subacute ruminal acidosis. Four Holstein bulls were used in this crossover study with a 2-week wash-out period. Anti-LPS antibody (0 or 4 g) was administered once daily for 14 days. Significantly lower ruminal LPS and higher 1-h mean ruminal pH were identified in the 4 g group. However, blood metabolites, acute-phase proteins, cytokines, and hepatic transcriptomes were not different between the two groups. Therefore, anti-LPS antibody administration mitigated ruminal LPS release and pH depression without accompanying responses in acute-phase inflammation or hepatic transcriptomic expression.

6.
Journal of Veterinary Science ; : e34-2021.
Artigo em Inglês | WPRIM | ID: wpr-901458

RESUMO

Anti-lipopolysaccharide (LPS) antibody administration has the potential benefits of neutralizing and consequently controlling rumen-derived LPS during subacute ruminal acidosis. Four Holstein bulls were used in this crossover study with a 2-week wash-out period. Anti-LPS antibody (0 or 4 g) was administered once daily for 14 days. Significantly lower ruminal LPS and higher 1-h mean ruminal pH were identified in the 4 g group. However, blood metabolites, acute-phase proteins, cytokines, and hepatic transcriptomes were not different between the two groups. Therefore, anti-LPS antibody administration mitigated ruminal LPS release and pH depression without accompanying responses in acute-phase inflammation or hepatic transcriptomic expression.

7.
Annals of Dermatology ; : 645-653, 2019.
Artigo em Inglês | WPRIM | ID: wpr-762392

RESUMO

BACKGROUND: Face-lifting procedures are often performed to hide the effects of aging. Thread-lifting, a minimally invasive technique for the correction of facial aging, has become increasingly popular, and various materials for the procedure have been developed. OBJECTIVE: This study compared tissue responses to two types of threading sutures placed under rat skin: polypropylene (PP) monofilament mesh suspension thread (a novel face-lifting material) and polydioxanone (PDO) barbed thread. METHODS: Eight rats each were assigned to the PP monofilament mesh suspension, PDO barbed thread, and control groups. Tissue reactions were evaluated 28 days after subcutaneous loading of the materials. RESULTS: Significant increases in tensile strength and the mean area occupied by collagen fibers were evident in skin loaded with PDO barbed thread and PP monofilament mesh suspension thread compared to control skin (p<0.05). Compared to sites loaded with PDO barbed thread, those loaded with PP monofilament mesh suspension thread showed a significant increase in the number of collagen fibers and a lower grade of inflammation (p<0.05). CONCLUSION: PP monofilament mesh suspension thread has skin-rejuvenating effects comparable to those of PDO barbed thread, but induces a less severe inflammatory response. This indicates that it is a safe and effective material for use in thread-lifting procedures on aging skin.


Assuntos
Animais , Ratos , Envelhecimento , Colágeno , Inflamação , Polidioxanona , Polipropilenos , Pele , Suturas , Resistência à Tração
8.
Journal of Veterinary Science ; : 95-97, 2019.
Artigo em Inglês | WPRIM | ID: wpr-758877

RESUMO

A total of 123 Coxiella burnetii strains detected in cattle from a nationwide survey in Korea were classified into five genomic groups: I (0.8%), II (14.6%), III (12.2%), IV (66.7%), and V (5.7%). Acute Q-fever strains (Groups I, II, and III) comprised 27.6% and chronic strains (Groups IV and V) comprised 72.4%. At a dairy farm where both types were present, the detection rate was 6.7-times higher than that of another farm where only chronic strains were detected. Both acute and chronic Q-fever strains are widespread in Korea, and their presence could represent an active transmission to livestock and humans.


Assuntos
Animais , Bovinos , Humanos , Agricultura , Coxiella burnetii , Coxiella , Coreia (Geográfico) , Gado
9.
Korean Journal of Dermatology ; : 225-227, 2018.
Artigo em Inglês | WPRIM | ID: wpr-713417

RESUMO

No abstract available.


Assuntos
Músculo Masseter
10.
Intestinal Research ; : 145-152, 2015.
Artigo em Inglês | WPRIM | ID: wpr-144346

RESUMO

BACKGROUND/AIMS: Metformin use has been associated with decreased colorectal cancer risk and mortality among diabetic patients. Recent research suggests that metformin use may decrease the incidence of colorectal adenomas in diabetic patients with previous colorectal cancer. This study aimed to assess the clinical effect of metformin use on the development of colorectal adenomas in diabetic patients without previous colorectal cancer. METHODS: Among 604 consecutive diabetic patients who underwent colonoscopic surveillance after initial colonoscopy between January 2002 and June 2012, 240 patients without previous colorectal cancer were enrolled in this study and were divided in two groups: 151 patients receiving metformin and 89 patients not receiving metformin. Patient demographics and clinical characteristics as well as the colorectal adenoma incidence rate were retrospectively analyzed. RESULTS: The incidence rate of total colorectal adenomas was not different according to metformin use (P=0.349). However, the advanced adenoma incidence rate was significantly lower in the metformin group compared with the non-metformin group (relative risk [RR], 0.09; P=0.011). Metformin use was independently associated with a decreased incidence of advanced colorectal adenomas after adjustment for clinically relevant factors (RR, 0.072; P=0.016). In addition, the cumulative development rate of advanced adenomas during follow-up was significantly lower in the metformin group compared with the non-metformin group (P=0.007). CONCLUSIONS: Metformin use in diabetic patients without previous colorectal cancer is associated with a lower risk of advanced colorectal adenomas.


Assuntos
Humanos , Adenoma , Colonoscopia , Neoplasias Colorretais , Demografia , Diabetes Mellitus , Seguimentos , Incidência , Metformina , Mortalidade , Estudos Retrospectivos
11.
Intestinal Research ; : 145-152, 2015.
Artigo em Inglês | WPRIM | ID: wpr-144339

RESUMO

BACKGROUND/AIMS: Metformin use has been associated with decreased colorectal cancer risk and mortality among diabetic patients. Recent research suggests that metformin use may decrease the incidence of colorectal adenomas in diabetic patients with previous colorectal cancer. This study aimed to assess the clinical effect of metformin use on the development of colorectal adenomas in diabetic patients without previous colorectal cancer. METHODS: Among 604 consecutive diabetic patients who underwent colonoscopic surveillance after initial colonoscopy between January 2002 and June 2012, 240 patients without previous colorectal cancer were enrolled in this study and were divided in two groups: 151 patients receiving metformin and 89 patients not receiving metformin. Patient demographics and clinical characteristics as well as the colorectal adenoma incidence rate were retrospectively analyzed. RESULTS: The incidence rate of total colorectal adenomas was not different according to metformin use (P=0.349). However, the advanced adenoma incidence rate was significantly lower in the metformin group compared with the non-metformin group (relative risk [RR], 0.09; P=0.011). Metformin use was independently associated with a decreased incidence of advanced colorectal adenomas after adjustment for clinically relevant factors (RR, 0.072; P=0.016). In addition, the cumulative development rate of advanced adenomas during follow-up was significantly lower in the metformin group compared with the non-metformin group (P=0.007). CONCLUSIONS: Metformin use in diabetic patients without previous colorectal cancer is associated with a lower risk of advanced colorectal adenomas.


Assuntos
Humanos , Adenoma , Colonoscopia , Neoplasias Colorretais , Demografia , Diabetes Mellitus , Seguimentos , Incidência , Metformina , Mortalidade , Estudos Retrospectivos
12.
Allergy, Asthma & Respiratory Disease ; : 124-127, 2015.
Artigo em Coreano | WPRIM | ID: wpr-83898

RESUMO

PURPOSE: Adverse cutaneous reactions to antituberculous drugs (ATD), such as maculopapular eruption (MPE), are the most common causes of discontinuation of scheduled treatment of tuberculosis. We previously reported that tumor necrosis factor (TNF)-alpha genetic polymorphism -308G/A is significantly associated with ATD-induced hepatitis. This study aimed to investigate associations between TNF-alpha -308G/A and ATD-induced MPE. METHODS: Patients with ATD-induced MPE and controls without any adverse reactions to ATD were recruited from the database of the Adverse Drug Reaction Pharmacogenomic Research Group database of Korea. We compared the genotype frequency of TNF-alpha-308G/A between patients with ATD-induced MPE and ATD-tolerant controls. RESULTS: A total of 69 patients with ATD-induced MPE and 229 control subjects were enrolled for this study. There were no significant differences in genotype frequency between the patients and the controls, suggesting lack of associations between TNF-alpha-308G/A and ATD-induced MPE. CONCLUSION: The TNF-alpha genetic polymorphism -308G/A may not be related to the development of ATD-induced MPE, in contrast to ATD-induced hepatitis. These findings suggest that associations between TNF-alpha-308G/A and ATD-induced adverse reactions can be phenotype-specific.


Assuntos
Humanos , Antituberculosos , Toxidermias , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Genótipo , Hepatite , Coreia (Geográfico) , Polimorfismo Genético , Tuberculose , Fator de Necrose Tumoral alfa
13.
The Korean Journal of Gastroenterology ; : 39-41, 2014.
Artigo em Coreano | WPRIM | ID: wpr-155057

RESUMO

Skin metastasis from internal carcinoma rarely occurs and it has an incidence of 0.7% to 9%. Although the prognosis of the skin metastases varies considerably depending on the type of the primary malignancy, presence of metastatic skin cancer usually implies a widespread systemic disease and a high mortality. A 50-year-old Korean male patient visited Dankook University Hospital for evaluation of skin rash on his whole abdomen of about 1 month's duration. He had undergone laparoscopy-assisted distal gastrectomy due to early gastric cancer about 3 months ago. He did not complain of any noticeable symptoms like febrile sense or pruritus. Skin biopsy was performed on the periumbilical area at previous port site and around the scar. Microscopic examination revealed multiple malignant cells in lymphatic spaces, consistent with metastatic carcinoma. He was therefore diagnosed with isolated skin metastasis from early gastic cancer. Because of patient's poor liver function, systemic chemotherapy could not be performed and only best supportive care was provided. Herein, we report a rare case of cellulitis-like skin metastasis from early gastric cancer with a brief review of the literature.


Assuntos
Humanos , Masculino , Pessoa de Meia-Idade , Carcinoma/diagnóstico , Exantema , Queratina-7/metabolismo , Laparoscopia , Metástase Linfática , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons , Neoplasias Cutâneas/metabolismo , Neoplasias Gástricas/diagnóstico , Tomografia Computadorizada por Raios X
14.
Anesthesia and Pain Medicine ; : 179-184, 2014.
Artigo em Coreano | WPRIM | ID: wpr-165336

RESUMO

BACKGROUND: Remifentanil efficiently blunts the stress response during endotracheal intubation, but also causes hypotension, especially in geriatric patients. Hence, this study was designed to compare the hemodynamic changes during the induction with propofol or etomidate in geriatric patients. METHODS: Sixty ASA physical status class I or II geriatric patients, who were scheduled for elective surgery, were randomly assigned to two groups (n = 30 each). Induction was performed with either propofol (2 mg/kg mixed with lidocaine 40 mg, Group P) or etomidate (0.2 mg/kg, Group E). Both groups received a bolus dose of remifentanil (1 microg/kg), followed with continuous administration (0.1 microg/kg/min). An additional bolus dose (50 microg) was repeated, if needed. The systolic, diastolic, mean arterial blood pressure, heart rates and cardiac index were measured before induction (baseline vital signs), after propofol or etomidate administration, before intubation, immediately after intubation and at 1, 3, 5 and 10 minutes after intubation. RESULTS: Patient characteristics and baseline vital signs were similar in both groups. Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and cardiac output were significantly decreased in group P compared with those in group E (P < 0.05). Heart rates decreased after the injection of both propofol or etomidate, but were recovered after intubation. 5 patients in group P and 14 patients in group E needed an additional bolus dose of remifentanil (P < 0.05). CONCLUSIONS: Etomidate can be used safely with remifentanil for the stable induction of anesthesia in geriatric patients.


Assuntos
Humanos , Anestesia , Anestesia Geral , Pressão Arterial , Pressão Sanguínea , Débito Cardíaco , Etomidato , Frequência Cardíaca , Hemodinâmica , Hipotensão , Intubação , Intubação Intratraqueal , Lidocaína , Propofol , Sinais Vitais
15.
Translational and Clinical Pharmacology ; : 22-29, 2014.
Artigo em Inglês | WPRIM | ID: wpr-107309

RESUMO

Ibandronate (a bisphosphonate) is commonly used as an treatment of osteoporosis in combination with vitamin D. Monthly DP-R206-a novel, fixed-dose combination tablet (150 mg ibandronate/24,000 IU vitamin D3)-was recently developed to enhance patient compliance. This open, randomized, two-period crossover study was conducted to compare the pharmacokinetics of ibandronate when administered as DP-R206 or 150 mg ibandronate to healthy adult volunteers. Each volunteer was randomly allocated to receive single-dose DP-R206 or ibandronate with a 28-day washout period between treatments. Blood samples were assessed using pharmacokinetic analysis. Plasma ibandronate concentrations were determined using liquid chromatography-tandem mass spectrometry. Safety and tolerability assessments were performed throughout the study. In total, 103 participants received the study drugs and 72 participants completed the study. The geometric mean ratios (DP-R206/ibandronate) of the maximum concentration (C(max)) and the area under the plasma concentration time curve from time zero to the last concentration (AUC(last)) values were 0.959 (90% CI: 0.820-1.120) and 0.924 (90% CI: 0.805-1.060), respectively. The frequencies of adverse events (AEs) and drug reactions were similar between treatment groups, and all AEs were recovered without sequalae. Ibandronate pharmacokinetics, tolerability, and safety are comparable when administered to healthy individuals, regardless if administered as DP-R206 or ibandronate.


Assuntos
Adulto , Humanos , Estudos Cross-Over , Espectrometria de Massas , Osteoporose , Cooperação do Paciente , Farmacocinética , Plasma , Vitamina D , Vitaminas , Voluntários
16.
Korean Journal of Pancreas and Biliary Tract ; : 37-41, 2014.
Artigo em Coreano | WPRIM | ID: wpr-48143

RESUMO

A bezoar is a mass formed by the accumulation of digested food. A biliary bezoar, namely a bezoar formed in the bile duct, is rare, which occurs mostly in patients who formerly underwent cholecystectomy. It appears that incompetent sphincter produces occasional reverse flow of foreign bodies including undigested food from the alimentary canal into the bile tract. Surgical treatment is used for huge biliary bezoar which is too huge to be removed by nonsurgical treatment. Extracorporeal shock wave lithotripsy (ESWL) is mostly used to fragment renal or urinary calculi, but may be sparingly used against biliary calculi. This is to report the rare case of a patient with biliary bezoar who formerly underwent open cholecystectomy and choledocoduodenostomy. The patient's huge biliary bezoar was removed by ESWL and the successive execution of endoscopic retrograde cholangio pancreatography (ERCP). ESWL is expected to be a comparatively safe and convenient solution to huge biliary bezoars.


Assuntos
Humanos , Bezoares , Bile , Ductos Biliares , Colecistectomia , Corpos Estranhos , Cálculos Biliares , Litotripsia , Choque , Cálculos Urinários
17.
The Korean Journal of Thoracic and Cardiovascular Surgery ; : 240-248, 2014.
Artigo em Inglês | WPRIM | ID: wpr-215833

RESUMO

BACKGROUND: Open heart surgery using cardiopulmonary bypass (CPB) is considered one of the most frequent surgical procedures in which acute kidney injury (AKI) is a frequent and serious complication. The aim of the present study was to evaluate the efficiency of neutrophil gelatinase-associated lipocalin (NGAL) as an early AKI biomarker after CPB in cardiac surgery (CS). METHODS: Thirty-seven adult patients undergoing CS with CPB were included in this retrospective study. They had normal preoperative renal function, as assessed by the creatinine (Cr) level, NGAL level, and estimated glomerular filtration rate. Serial evaluation of serum NGAL and Cr levels was performed before, immediately after, and 24 hours after the operation. Patients were divided into two groups: those who showed normal immediate postoperative serum NGAL levels (group A, n=30) and those who showed elevated immediate postoperative serum NGAL levels (group B, n=7). Statistical analysis was performed using Statistical Package for the Social Sciences version 18. RESULTS: Of the 37 patients, 6 (6/37, 16.2%) were diagnosed with AKI. One patient belonged to group A (1/30, 3.3%), and 5 patients belonged to group B (5/7, 71.4%). Two patients in group B (2/7, 28.5%) required further renal replacement therapy. Death occurred in only 1 patient (1/37, 2.7%), who belonged to group B. CONCLUSION: The results of this study suggest that postoperative plasma NGAL levels can be used as an early biomarker for the detection of AKI following CS using CPB. Further studies with a larger sample size are needed to confirm our results.


Assuntos
Adulto , Humanos , Injúria Renal Aguda , Biomarcadores , Ponte Cardiopulmonar , Creatinina , Taxa de Filtração Glomerular , Lipocalinas , Neutrófilos , Plasma , Terapia de Substituição Renal , Estudos Retrospectivos , Tamanho da Amostra , Ciências Sociais , Cirurgia Torácica
18.
Journal of the Korean Society of Emergency Medicine ; : 132-136, 2014.
Artigo em Inglês | WPRIM | ID: wpr-199075

RESUMO

Chylothorax, a relatively rare condition of pleural effusion, is defined as an accumulation of chyle resulting from damage to the thoracic duct associated with chyle leakage from the lymphatic system into the pleural cavity. The etiologies of this condition are numerous, and the most important approach for management of chylothorax is to determine the definite cause. We report on a case of an unusual complication of chylothorax that occurred after central catheterization and direct instillation of total parenteral nutrition into the pleural cavity.


Assuntos
Cateterismo , Cateterismo Venoso Central , Catéteres , Quilo , Quilotórax , Sistema Linfático , Nutrição Parenteral , Nutrição Parenteral Total , Cavidade Pleural , Derrame Pleural , Veia Subclávia , Ducto Torácico
20.
Journal of Korean Society for Clinical Pharmacology and Therapeutics ; : 95-103, 2013.
Artigo em Coreano | WPRIM | ID: wpr-30069

RESUMO

BACKGROUND: Amlodipine is a third-generation dihydropyridine calcium channel blocker, which has proven to be a useful drug against hypertension or angina. METHODS: This randomized, open-label, two-period, two-treatment, single-dose, crossover study was conducted in twenty healthy male volunteers. Subjects were administered 5 mg of the test or reference formulation. After 2-week washout period, the other formulation was administered. Blood samples were collected up to 144 hours after drug administration, and plasma amlodipine concentrations were determined by validated liquid chromatography-tandem mass spectrometry. Drug safety was assessed using measurement of vital signs, physical examinations, laboratory test, electrocardiograms, and adverse event monitoring. RESULTS: All subjects were completed this study. The geometric mean ratios of Cmax and AUClast were 1.078 (90 % CI, 0.968 - 1.200) and 1.095 (90 % CI, 1.011 - 1.186), respectively. There were no serious adverse events were reported by both formulations. CONCLUSION: This study showed the test and reference formulations had similar pharmacokinetics and safety profiles.


Assuntos
Humanos , Masculino , Anlodipino , Canais de Cálcio , Estudos Cross-Over , Eletrocardiografia , Voluntários Saudáveis , Hipertensão , Espectrometria de Massas , Farmacocinética , Exame Físico , Plasma , Sinais Vitais
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