NCT00776646

Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two- Sequence, Single-Dose, Crossover Bioavailability Study Comparing Hydrochlorothiazide 50 mg Tablet of Ohm Laboratories (A Subsidiary of Ranbaxy Pharmaceuticals USA) With Hydrochlorothiazide 50 mg Tablet of IVAX Pharmaceuticals in Healthy, Adult, Human, Male Subjects Under Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting condition

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two- sequence, single-dose, crossover bioavailability study comparing hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of Ohm Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet, containing 50 mg of hydrochlorothiazide of IVAX Pharmaceuticals, in healthy, adult, human, male subjects under fasting condition. During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical, serology parameters and urine analysis) at base line. Laboratory parameters of hematology and biochemistry were repeated at the end of the study. In addition serum electrolytes Sodium, Potassium and Chloride were measured on admission and at the discharge of each period. A total of 36 subjects were randomized to receive single oral dose of hydrochlorothiazide 50 mg tablet and 31 subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	hydrochlorothiazide 50 mg tablet

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-06-01
• Completion: 2006-08-01
• First posted: 2008-10-21
• Last updated: 2008-10-21