Fed Clinical Trial
Official title:
A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Lisinopril Tablets 40 mg With Zestril® (Lisinopril) 40 mg Tablets in Normal, Healthy, Adult, Male and Female Human Subjects Under Fed Conditions.
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 fed condition in normal, healthy, adult, male and female human subjects.
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
fed 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 18 days including washout period of 14
days between administrations of study drug in each study period.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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