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Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions

Fasting 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 Fasting Condition

Clinical Trial Summary

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 fasting condition in normal, healthy, adult, human subjects.

Clinical Trial Description

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 fasting 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01831700
Study type Interventional
Source IPCA Laboratories Ltd.
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date October 2012
View Details
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