ORAL BIO-EQUIVALENCE STUDY OF FIXED DOSE COMBINATION OF OLMESARTAN 40mg+AMLODIPINE 10mg+ HYDROCHLOROTHIAZIDE 25mg TABLETS IN HEALTHY HUMAN VOLUNTEERS

This present bioequivalence study was designed to determine t he bioavailability and bioequivalence of Olmesartan 40mg+Amlodipine 10mg+ Hydrochlorothiazide 25mg tablets in comparison with TRIBENZOR ® tablets after single dose administration under fasting conditions in healthy adul t male subjects. Therefore the design of an open label, b alanced, randomized, single dose, two-treatment, two-period cross over study with a wash-out period of at least 15 days was used. The pharmacokinetic parameters including C max , AUC 0-t, AUC 0-inf and T max were analyzed using the non-compartmental model. Drug safety and tolerability were assessed. The primary pharmacokinetic parameters (C max , AUC 0-t and AUC 0-inf ) 90%CI were within the 80 to 125% interval required for bioequival ence as stipulated in the current regulations of the USFD A acceptance criteria. The 90% confidence intervals for the ratios of the ln-transformed Cmax and AUC 0→72 for Olmesartan were 98.788%99.602% and 98.637%-98.835% respectively and for Amlodipine were 99.976%-101.918% and 104.957%-111.670% respectively and for hydrochlorothiazide were 98.082% -99.623% and 95.301%-98.406% respectively. Eighteen volunteers had completed all treatment periods. The pharmacokinetic par ameters of test product assessed were within the acceptable limits of Bioequivalence 80-125%.