NCT00872781

Bioequivalence Study of Quinapril Hydrochloride 20 mg and Hydrochlorothiazide 25 mg Tablets Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study Comparing Fixed Dose Combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg Tablets of OHM Laboratories Inc (a Subsidiary of Ranbaxy Pharmaceuticals Inc) With ACCURETICTM Tablets (Containing Fixed Dose Combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg) of Parke Davis, in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study was conducted as a open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing Quinapril hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg of OHM Laboratories Inc (a subsidiary of Ranbaxy pharmaceuticals Inc) with AccureticTM tablets 20 mg/ 25 mg (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) manufactured by Parke Davis Pharmaceuticals Limited, Vega Baja, PR 00694, Made in Germany and distributed by Parke-Davis, Division of Pfizer Inc. NY, NY 10017 in healthy, adult, male, human subjects under fasting condition.

Detailed description

Following an overnight fast of at least 10 hour, a single oral dose of Quinapril hydrochloride and Hydrochlorothiazide tablets 20 mg/25 mg or AccureticTM tablet 20 mg/ 25 mg (containing quinapril hydrochloride 20 mg and hydrochlorothiazide 25 mg) was administered during each period of the study, along with 240 mL of drinking water at ambient temperature and under low light condition and supervision of a trained study personnel. A total of sixty-four (64) subjects were enrolled in the study. One subject (subject number 18) dropped out of the study and two subjects (subject number 47 and 50) were withdrawn from the study. Hence Sixty-one (61) subjects completed both the periods of the study. For Quinapril and Hydrochlorothiazide pharmacokinetic and statistical analyses were performed on data from 61 subjects who completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	fixed dose combination of Quinapril HCl 20 mg and Hydrochlorothiazide 25 mg tablets

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2009-03-31
• Last updated: 2009-03-31

Locations

1 site across 1 country: India