NCT00779233

Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fasting Conditions

A Study to Compare the Relative Bioavailability of Ranbaxy and GlaxoSmithKline Formulation of Zidovudine Tablets 300 mg in Healthy Adult Volunteers Under Fasting Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the relative bioavailability of the test formulation of Zidovudine 300 mg tablets with an already marketed reference formulation RETROVIR ® 300 mg tablets (GlaxoSmithKline), under fasted conditions in healthy male and female adult subjects.

Detailed description

A randomized, single dose, two way crossover study was conducted with up to 32 healthy, male and female adult subjects to compare two Zidovudine 300 mg tablet formulations under fasting conditions. In each period one x 300 mg tablet was administered to fasting subjects. Subjects received the test product in one study period and the reference product in the other period. The order of the treatment administration was as per the dosing randomization schedule. Each dose was separated by at least a 7 day interval. A total of thirty two (32) subjects (23 males and 9 females) were enrolled for the study, of which only twenty eight (28) subjects completed the clinical portion of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zidovudine tablets 300 mg

Timeline

• Start date: 2004-09-01
• Primary completion: 2004-09-01
• Completion: 2004-10-01
• First posted: 2008-10-24
• Last updated: 2008-10-24

Locations

1 site across 1 country: United States