Objective of this pivotal study was to assess the bioequivalence between Test Product: Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India and the corresponding Reference Product: Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA under fed condition in normal, healthy, adult, human subjects in a randomized crossover study.~The study was conducted with 48 healthy adult subjects. In each study period, a single Lisinopril and Hydrochlorothiazide Tablets (20+25) mg 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 clinical phase was 12 days, including the washout period of 7 days between each study period.
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult, human subjects.