NCT00779376

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

Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and GlaxoSmithKline (Retrovir ® ) 300 mg Zidovudine Tablets in Healthy Adult Volunteers Under Fed Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions

Detailed description

This was an open label, randomized, single dose, 2-way crossover, comparative bioavailability study performed on 68 healthy adult volunteers. In each period, subjects were housed from at least 10 hours before dosing until after the 12 hour blood draw. Single oral dose 300 mg Zidovudine doses were separated by a washout period of 7 days. A total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in the study, of which sixty five (65) subjects (29 males and 36 females) completed the clinical portion of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zidovudine 300mg tablets

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-03-01
• Completion: 2005-04-01
• First posted: 2008-10-24
• Last updated: 2008-10-24

Locations

1 site across 1 country: Canada