NCT00778713

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of Fosinopril sodium and hydrochlorothiazide 20-12.5 mg tablets of 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 non-fasting conditions.

Detailed description

This study was a single dose, randomized, two-period, two-sequence, crossover design study. It was used to evaluate the relative bioavailability of the Fosinopril sodium and hydrochlorothiazide tablet products when dose (1 x 20/ 12.5 mg) under non-fasting conditions. There was a washout of at least a week between the two study periods. A total of thirty six (36) healthy adult volunteers were recruited in the study of which only thirty three (33) subjects i.e. 18 males and 15 females completed the clinical portion of 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