Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers

摘要: This study was conducted in order to assess the bioequivalence of two different coated tablet formulations containing 5 mg finasteride (CAS 98319-26-7). Twenty-six healthy volunteers were enrolled an open, randomised, crossover single dose with 2 periods x sequences and a minimum washout period 7 days. Plasma samples obtained over 24 h (at baseline, +0.5 h, +1 +1.5 +2 +2.5 +3 3.5 +4 +4.5 +5 +6 +8 +10 +12 +16 +24 after administration). Finasteride levels determined by high-pressure liquid chromatography tandem mass detection, HPLC-MS/ MS, (LOQ 0.50 ng/mL). Pharmacokinetic parameters used for assessment (AUClast Cmax main evaluation criteria, however, AUCinf also analysed) from concentration data using non-compartmental analysis. The 90 % confidence intervals (obtained ANOVA) 86.31-98.69 Cmax, 95.40-104.88 AUClast 96.20-105.81 that is, they all within predefined ranges. It may be therefore concluded evaluated are bioequivalent terms rate extent absorption.