Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril Tablets 40 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Zestril® (Lisinopril) 40 mg Tablets of AstraZeneca Pharmaceuticals LP USA, under fasting condition in normal, healthy, adult, male and female human subjects in a randomized crossover study.~The study was conducted with 40 healthy adult subjects. In each study period, a single 40 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.~The duration of the clinical phase was approximately 19 days including washout period of 15 days between administrations of study drug in each study period.
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal, healthy, adult, male and female human subjects.