Bioequivalency Study of Zidovudine Under Fasting Conditions

ClinicalTrials.gov ID: NCT00602550

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Study identification

NCT ID: NCT00602550
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Roxane Laboratories; Industry
Enrollment: 52 participants

Conditions and interventions

Conditions

HIV Infections

Interventions

Zidovudine Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2003 (Type not available)
Primary completion: Jun 2003 (Actual)
Completion: Jun 2003 (Actual)
Last update posted: Jan 23, 2018

2003

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
CEDRA Clinical Research	Austin	Texas	78759	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00602550, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 23, 2018 · Synced Nov 12, 2026