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Objective: To investigate the differences in the pharmacokinetics of dexamethasone between fasting and high-fat meals in Chinese volunteers. Methods:Twenty volunteers were given a 1.5 mg dose of dexamethasone tablets before and after a high-fat meal. After the plasma sample was prepared by protein precipitation, the plasma concentration of dexamethasone was determined by LC-MS/MS. The main pharmacokinetic parameters were calculated with DAS 3.2.1 software. The statistical analysis was carried out with SPSS 24 software. Results:The calibration curve for dexamethasone in human plasma showed a good linearity within the concentration range of 0.100-20.0 μg/L. The main pharmacokinetic parameters of dexamethasone for the fasting and high-fat meal conditions were as follows: C max (17.79±4.44)and(12.95±4.05)μg/L, T max (0.78±0.49)and(1.58±0.91)h, t 1/2(4.15±0.90)and(4.88±1.35) h, AUC 0-t (62.08±14.23)and(75.84±26.84)μg•h/L, AUC 0-∞ (63.29±15.13)and(79.58±30.33)μg•h/L, MRT 0-t (4.90±0.82)and (5.93±1.11)h, and MRT 0-∞ (5.39±1.06)and(6.93±1.83)h, respectively. The t-test results showed that there were significant differences in T max, C max, MRT 0-t and MRT 0-∞ (P0.05)between the fasting and high-fat meal groups. Conclusion:High-fat meals could significantly delay the time to reach maximum concentration, increase the mean residence time and reduce the peak concentration of dexamethasone, but does not influence the exposure amount.
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AIM: To evaluate the bioequivalence and safety of two cefdinir capsules under a fasting/high-fat fed condition in healthy people. METHODS: Twenty-six healthy volunteers were randomized to cross-test single-dose oral cefdinir capsules or reference preparations for fasting. Thirty-six healthy volunteers were randomized to crossed single-dose oral cefdinir capsule test preparations or reference preparations after high-fat meals. The blood concentration of cefdinir was determined by liquid chromatography-mass spectrometry (LC-MS/MS). Pharmacokinetic parameters and equivalence were calculated and evaluated using WinNonlin 6.4 and SAS 9.4 software. RESULTS: The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by twenty-five healthy volunteers for fasting were 93.01%-109.22%, 96.16%-110.06%, and 96.38%-110.16%, all at 80.00%-125.00% within the range of bioequivalence. The 90% confidence intervals of the geometric mean ratios of the Cmax, AUC0-t, and AUC0-∞ for the test and reference preparations of cefdinir capsules taken by thirty-six healthy volunteers for a high-fat fed were 93.91%-103.28%, 92.93%-100.72% and 92.97%-101.26%, all at 80.00%-125.00% within the range of bioequivalence. The incidences of adverse reactions in healthy volunteers taking cefdinir capsules for the fasting test and reference preparations were 12.0% and 11.5%, respectively. The incidence of adverse reactions in healthy volunteers taking cefdinir capsules after the meal was 25.0% and 27.8%, respectively. CONCLUSION: The test preparation of cefdinir capsules and the reference preparation are bioequivalent, and the volunteers show good safety and tolerability under the test dose.
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ABSTRACT Objective We investigated the postprandial response of lipid markers to a high-fat meal (HFM) with two different beverages in apparently healthy normal-weight and overweight/obese women. Subjects and methods This crossover, randomized study enrolled 36 women, of whom 21 had normal weight (body mass index [BMI] 22 ± 1.8 kg/m2) and 15 had overweight/obesity (BMI 31 ± 3.7 kg/m2). In two different test days, the participants ingested a HFM (37% of energy as saturated fat) with 500 mL of water (HFM-W) or 500 mL of orange juice (HFM-OJ). Blood samples were collected at baseline (12-hour fasting), and at 2, 3, and 5 hours postprandial. The analysis included fasting and postprandial total cholesterol, HDL-c, LDL-c, triglycerides (TG), uric acid, and complement C3. Brazilian Clinical Trials Registry (ReBEC); Primary Identification Number: RBR-2h3wjn (www.ensaiosclinicos.gov.br). Results TG levels increased at 3 hours with HFM-OJ in normal-weight women (p = 0.01) and returned to normal levels at 5h. TG increased at 3 hours with HFM-W (p = 0.01) and HFM-OJ (p = 0.02), and remained high at 5 hours (p = 0.03) in overweight/obese women. Complement C3 remained unchanged, but showed different responses between meals (p = 0.01 for positive incremental area under the curve [piAUC] HFM-OJ vs. HFM-W, respectively). Conclusions In apparently healthy overweight/obese women compared with normal-weight ones, the concomitant intake of orange juice with a HFM prolonged postprandial lipemia but had no effect on postprandial complement C3 concentrations.
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Humans , Female , Adult , Young Adult , Postprandial Period/physiology , Citrus sinensis , Overweight/blood , Diet, High-Fat , Fruit and Vegetable Juices , Hyperlipidemias/blood , Reference Values , Triglycerides/blood , Dietary Fats/blood , Body Mass Index , Cholesterol/blood , Analysis of Variance , Fasting , Statistics, Nonparametric , Cross-Over StudiesABSTRACT
Aim To determine the effects of high-fat meal and ABCB1 C3435 T polymorphism on the phar-macokinetics of nifedipine in the healthy Chinese sub-jects. Methods A total of 90 unrelated healthy Han subjects were divided into two groups:fasting group ( n=45 ) and high-fat meal group ( n=45 ) and then they received a single oral dose of 90 mg extended release tablet. Multiple blood samples were collected after 48 h, and the plasma concentrations of nifedipine were determined by high performance liquid chromatogra-phy- mass spectrometry ( LC-MS ) . PCR-restriction fragment length polymorphism ( RFLP ) analysis was performed to detect the C3435 T polymorphism in AB-CB1 gene. Results The numbers of individuals carry-ing C/C, C/T and T/T genotypes in fasting group were 13, 24 and 8, respectively. The mean area under the curve ( AUC0-∞) in subjects carrying T/T genotype distinctly increased by 46. 34% compared with subjects with C/C genotype, but there was no statistically sig-nificant difference (P=0. 066). In addition, pharma-cokinetic parameters including Tpeak, Cmax and AUC0-48 had statistically significant differences between fasting group and high-fat meal group ( all P<0. 05 ) . Con-clution High-fat meal can speed the absorption and increase the extent of nifedipine absorption; ABCB1 C3435 T polymorphism almost does not affect the phar-macokinetics of nifedipine.
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Objective To evaluate the applications of magnetic resonance cholangiopancreatography (MRCP) after fat meal in the preoperative evaluation of biliary anatomy of living liver donors.Methods Fifty cases of the preoperative donors for living liver transplantation were included and all had the corresponding intraoperative cholangiography (IOC) information. The MRCP of the donors for living liver transplantation was performed before and after fat meal (two fried eggs). The visualization and diameter of the secondary bile duct were analyzed before and after the fat meal. The results of the biliary branching pattern by MRCP after fat meal were compared with the corresponding IOC results. The accuracy, sensitivity,specificity, positive predictive value and negative predictive value of MRCP after the fat meal in distinguishing normal and any type of variant biliary anatomy were calculated. Results In all cases,82% of the 50 cases in MRCP before the fat meal could meet the diagnosis needs of the preoperative evaluation,and 100% of the 50 cases in MRCP after the fat meal could meet the diagnosis needs. There was significant difference in the demonstration quality and diameter of the secondary bile duct in MRCP before and after the fat meal (P<0. 05). MRCP showed accurate anatomy of the biliary system, using IOC as the reference standard, in 49(98%) subjects. The sensitivity, specificity, positive predictive value and negative predictive value of MRC in distinguishing normal and any type of variant biliary anatomy were 98%,94. 7%, 100%, 10% and 96. 9%,respectively. Conclusion The MRCP after fat meal can clearly demonstrate the secondary bile duct and perfectly meet the needs of the preoperative evaluation of the living liver transplantation. The MRCP after fat meal and routine MRCP should be considered complementary to one another in order to avoid complications in living liver transplantation donors.
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so higher in diabetic patients 4 h after the meal (all P<0. 05). Positive correlation existed between serum triglycerides and white blood cell counting, neutrophils, and high-sensitivity C-reactive protein(r were between 0.268 and 0.548, all P<0.05).
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Few studies have examined short term responses to the different contents of carbohydrate or fat in the meal, although long term effects of the high fat meal have been considered as compound risk factor for metabolic disorders. The aim of this study was to investigate the postprandial changes of plasma glucose, insulin and lipids upon intakes of high carbohydrate or high fat meal in young healthy women. Subjects were randomly assigned to either the high carbohydrate meal (HCM, 75% carbohydrate, n=13) or the high fat meal (HFM, 60% fat, n=12) groups. The meals were prepared as isocaloric typical Korean menu. Blood samples were obtained prior to and 30, 60, 90, 120, 180 and 240 minute after the meal. There were no significant differences on fasting blood parameters including glucose, insulin, lipids concentrations between the groups prior to the test. The HCM had higher blood glucose and insulin concentrations, reached the peak at 30 min and maintained for 240 min compared to the HFM (P<0.05). The HFM had higher plasma triglyceride (TG) and free fatty acid (FFA) concentrations, reached the peak at 120 min and maintained for 240 min compared to the HCM (P<0.05). It is concluded that macronutrients content in the meal may be an important determinant of postprandial substrate utilization in healthy women.
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Female , Humans , Blood Glucose , Fasting , Glucose , Insulin , Kinetics , Meals , Plasma , Risk FactorsABSTRACT
Objective To explore the potential influence of a high-fat meal on systemic inflammation and fibrinolytic dysfunction in normocholesterolemic patients with essential hypertension(EH).Methods Plasma concentrations of lipids profiles,high-sensitivity C-reactive protein(hsCRP),plasminogen activator inhibitor type 1(PAI-1)and tissue plasminogen activator(t-PA)antigens in fasting state(F)and at 4 hours after a single high-fat meal(P)were measured in 54 EH patients and 30 healthy controls(Con).Results Postprandial triglyceride concentrations increased significantly in both hypertensive patients and healthy controls(P
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We experienced a case of primary intestinal lymphangiectasia in a 20-month-old boy, which was confirmed gastrofiberscopically and histologically only after a high-fat meal before the procedure. A characteristic endoscopic finding was the appearance of tiny white dots scattered in the duodenal mucosa, which were proved dilated lymph vessels in the lamina propria on histological examination. Treatment with low-fat diet and medium chain triglycerides supplementation was satisfactory.
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Humans , Infant , Male , Diagnosis , Diet, Fat-Restricted , Meals , Mucous Membrane , TriglyceridesABSTRACT
Objective To study the change of postprandial triglyceride (TG) concentrations after a high-fat meal in patients with coronary heart diseases (CHD), patients with essential hypertension (EHP) and healthy controls, and to explore the optimal time point to measure postprandial TG metabolism. Methods Fifty-four CHD patients, thirty-six EHP patients and twenty-five healthy controls were recruited. The concentrations of serum TG in fasting state and at 2, 4, 5, 7 h after a single high-fat meal (800 kcal, including 50 g fat) were measured. Results The postprandial serum TG concentrations increased significantly at 2, 4, 5 h point in all subjects (all P