Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition

Fasting 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 Fasting Conditions.

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Fasting

• NCT number: NCT01735318
• Study type: Interventional
• Source: IPCA Laboratories Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Completion date: August 2012