NCT00777972

Bioequivalence Study of Fosinopril Sodium/ Hydrochlorothiazide 20/ 12.5 mg Tablets Under Fasting Conditions

A Bioequivalence Study of Test and Reference Fosinopril Sodium/ Hydrochlorothiazide 20/12.5 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets by Ranbaxy Laboratories Limited with that of Monopril ®.-HCT 20-12.5 mg tablets by Bristol-Meyers Squibb following a single oral dose (1 x 20-12.5 mg tablet) in healthy adult subjects under fasting conditions

Detailed description

This study was a single dose, randomized, two period, two treatment, two sequence crossover study design was used to evaluate the relative bioavailability of Fosinopril sodium and hydrochlorothiazide tablet products when dose (1 x 20-12.5 mg) under fasting conditions. The two periods of the study were separated by a washout period of at least a week. A total of 36 healthy adult subjects were enrolled in the study. Of all the subjects 34 subjects (21 males and 13 females) completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-03-01
• Completion: 2003-04-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States