NCT00776334

Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions

The Objective of This Study is to Compare the Relative Bioavailability of Fosinopril Sodium 40 mg Tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) With That of Monopril® (Bristol-Myers Squibb, Lot No. 1D47960), in Healthy Adult Subjects Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (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 40 mg tablets (Ranbaxy Laboratories Limited, Lot No. 1238312) with that of Monopril® in healthy adult subjects under fasting conditions.

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Fosinopril formulations comparing fosinopril 40mg tablets of Ranbaxy Laboratories with Monopril® in healthy, adult, human, subjects under fasting conditions Eligible subjects underwent pre-study examinations that included a physical examination, 12-1cad ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis C, HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test. Forty (40) subjects were enrolled in this study; 39 completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Fosinopril 40mg Tablets

Timeline

• Start date: 2002-10-01
• Primary completion: 2002-11-01
• Completion: 2002-12-01
• First posted: 2008-10-21
• Last updated: 2008-10-21

Locations

1 site across 1 country: United States