NCT01827878

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed 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 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.

Conditions

• Fed

Interventions

Type	Name	Description
DRUG	Lisinopril and Hydrochlorothiazide Tablets (20+25) mg	Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
DRUG	Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets	Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-04-10
• Last updated: 2013-04-10

Locations

1 site across 1 country: India