ORAL BIO-EQUVALENCE STUDY OF FIXED DOSE COMBINATION OF PANTOPRAZOLE 40mg AND CINITAPRIDE 3mg EXTENDED RELEASE CAPSULES IN HEALTHY HUMAN MALE VOLUNTEERS

This present bioequivalence study was designed to d etermine the bioavailability and bioequivalence of Pantoprazole 40mg+ Cinitapride 3mg Extended Release Capsules in comparison with CINTODAC (Pantoprazole 40mg+ Cinitapride 3mg Extended Release) Capsules after single dose administration under fasting conditions in healthy ad ult male subjects. Therefore the design of an open label, balanced, ra ndomized, single dose, two-treatment, two-sequence, two-period, crossover study with a wash-out period of at least 7 days was used. The primary pharmacokinetic parameters (C max , AUC 0t and AUC 0-inf ) 90%CI were within the 80 to 125% interval require d for bioequivalence as stipulated in the current regulations of the USFDA acceptance criteria. The 9 0% confidence interval for Pantoprazole log transfo rmed parameters Cmax and AUC 0-t were 97.655% to 98.567% and 96.365% to 99.525% respectively and for Cinitapride were 99.976%101.918% and 104.957%-111.670%. Fifteen volunteers had completed all treatment periods. There was no s ignificant difference between the two formulations. No serious adverse events related to the study drug were foun d.