Fed Clinical Trial
Official title:
A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg of M/s Ipca Laboratories Ltd., India With Zestoretic® 20/25 Lisinopril/Hydrochlorothiazide Tablets of M/s AstraZeneca Pharmaceuticals LP, USA in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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