Clinical Trials Directory

Trials / Completed

CompletedNCT00601562

Bioequivalency Study of Zidovudine Under Fed Conditions

A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fed Conditions

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Roxane Laboratories · Industry
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Conditions

Interventions

TypeNameDescription
DRUGZidovudine

Timeline

Start date
2003-06-01
Primary completion
2003-06-01
Completion
2003-06-01
First posted
2008-01-28
Last updated
2018-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00601562. Inclusion in this directory is not an endorsement.

Bioequivalency Study of Zidovudine Under Fed Conditions (NCT00601562) · Clinical Trials Directory