Pharmacokinetic Evaluation of a Gastrointestinal Motility Tretment of Drug in Healthy Human Volunteers (Cinitapride)

The study is to conduct the Bioequivalence study of an Antidepressant, in accordance with the regulatory authority. The BE study is conducted on a test product, ‘T’and reference product ‘R’. ‘T’, and ‘R’are oral Tablet containing drug Cinitapride. In a dose of 150mg. Drug Cinitapride is an Gastrointestinal motility treatment drug. The study objectives included: Assessment of the bioavailability of test product A while comparing with a reference product B in 6 normal, adult, human subjects under fasting condition. The bioequivalence assessed is to be assessed under following pharmacokinetic Parameters: AUC0-t, AUC0-∞, Cmax, Tmax, Kel, and t1/2. Monitoring of the adverse events and ensure safety of the subjects. Bioequivalence is evaluated by three pharmacokinetic parameters viz., AUC, Cmax and Tmax out of which AUC and Cmax are main parameter for evaluation. The pharmacokinetic parameters (AUC and Cmax) of Cinitapride are within the acceptable limits of bioequivalence 80% - 125%. Hence, it is concluded that single dose bioequivalence study of Cinitapride 3 mg tablet (each containing Cinitapride 3 mg) is bioequivalent with Cintpro 3 mg tablet (each containing Cinitapride 3 mg)