ABSTRACT
BACKGROUND: Erlotinib is a tyrosine kinase inhibitor prescribed for the treatment of non-small cell lung cancer and pancreatic cancer. The aim of this study was to compare the safety and pharmacokinetics (PK) of a generic (test) formulation of erlotinib with those of a reference formulation in healthy volunteers. METHODS: A randomized, open-label, single-dose two-treatment, two-period, two-sequence, crossover study was conducted in Clinical Trials Center, Chungnam National University Hospital with 40 healthy men. Subjects orally received either one 150 mg tablet of the test or the corresponding dose of the reference, and crossover phases were separated by 14-day washout. Plasma samples were collected up to 72 hr post-dose. Plasma erlotinib concentrations were determined by liquid chromatography-tandem mass spectrometry. PK parameters were calculated by non-compartmental analysis. The safety was monitored throughout the study. RESULTS: A total of 21 cases of adverse events were reported. They are mild and relieved without an intervention. There was no serious adverse event. Median times to peak concentration of two formulations were 3.0. Means [SD] for peak concentration (Cmax) and area under the plasma concentration-time curve (AUC) of the test were 1,298 [346] microg/L and 25,318 [7,668] hrxmicrog/L. Those of the reference were 1,193 [378] microg/L and 24,853 [8,419] hrxmicrog/L. Geometric mean ratios (90% confidence intervals) for the test to the reference were 1.10 (1.02-1.18) for Cmax and 1.02 (0.97-1.09) for AUC. CONCLUSION: Two formulations were safe and well-tolerated. PK findings suggest that the test formulation is equivalent to the reference in terms of pharmacokinetics.
Subject(s)
Humans , Male , Area Under Curve , Carcinoma, Non-Small-Cell Lung , Cross-Over Studies , Erlotinib Hydrochloride , Healthy Volunteers , Mass Spectrometry , Pancreatic Neoplasms , Pharmacokinetics , Plasma , Protein-Tyrosine Kinases , Therapeutic EquivalencyABSTRACT
OBJECTIVE: Few studies have examined the impact of chronic diseases on populations using a comprehensive health-related quality of life (HRQOL) in Korea. We assessed HRQOL of patients with 16 common chronic diseases. METHODS: We interviewed patients with chronic diseases (n=980) and healthy control (n=288) using two HRQOL measurements: Korean Medical Outcome Study Short Form-36 (KSF-36) and Korena EuroQol-5 Dimensions (KEQ-5D), and questions on sociodemographic and clinical characteristics. RESULTS: Each illness had a distinctive profile. Among disease groups, the KSF-36 global health score was highest in DM and lowest in fibromyalgia. The KSF-36 physical component summary score was highest in DM and lowest in osteoarthritis . The KSF-36 mental component summary score was highest in hypertension and lowest in fibromyalgia. The KEQ-5D utility score was highest in DM and lowest in fibromyalgia. The KEQ-5D visual analog score was highest in DM and lowest in liver cirrhosis. In correlation analysis, the KSF-36 physical component summary, mental component summary and five domains in KEQ-5D were well correlated with each others. CONCLUSION: Health related quality of life in Korean patients with chronic disease is lower than healthy control. Patients with hypertension and DM registered the two highest scores in global health but patients with fibromyalgia reported the worst health experience in global health.We can compare the profiles of the groups and determine the relative impact on the patients of the various diseases and these data will provide a baseline of the current health related quality of life of individuals suffering from a variety of conditions.
Subject(s)
Humans , Chronic Disease , Fibromyalgia , Hypertension , Korea , Liver Cirrhosis , Osteoarthritis , Outcome Assessment, Health Care , Quality of LifeABSTRACT
Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by the overprocuctionofautoantibodiesandthedepositionofimmune complexes in various organs. Unusual case of systemic lupus erythematosus (SLE) associated with minimal change nephrotic syndrome(MCNS) is described. A 30-year-old woman who has been diagnosed as SLE and treated with prednisolone presented symptoms of nephrotic syndrome. Renal biopsy revealed minor glomerular abnormalities without deposition of immune complexes. The initial heavy proteinuria promptly decreased after the prednisolone dosage was increased and disappeared 10 weeks later. She developed proteinuria again 3 years after the initial episode. Repeated renal biopsy revealed membranous nephropathy. T-cell dysfunction, which is present both in SLE and MCNS, might have triggered MCNS during the course of SLE.