NCT00778726

Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fasting Conditions

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine the bioavailability of benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy fasted subjects. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Detailed description

The study was performed as a single-dose (one 20 mg/25 mg tablet), two way crossover bioequivalence study with a wash out of 7 days between doses and with equal number of subjects randomly assigned to the sequence (AB or BA) in which they received the study Test (A) and Reference (B) treatments. Subjects were confined in the clinical facility for at least 10 hours before dosing and for 24 hours after dosing. Subjects were discharged after 24-hours blood sample and returned as outpatients for the remaining blood samples. Standardized meals were served and no caffeine, alcohol, or grapefruit-containing foods or beverages were allowed to be consumed 24 hours before dosing or throughout study confinement. A total of 42 non-smoking subjects (24 men and 18 women) were randomized to receive single oral dose of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg tablet and 41 subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets

Timeline

• Start date: 2004-09-01
• Primary completion: 2004-10-01
• Completion: 2004-12-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States