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NCT00602550 · ClinicalTrials.gov registry record · NA

Bioequivalency Study of Zidovudine Under Fasting Conditions

A NA study of HIV Infections, sponsored by Roxane Laboratories.

Completed
Registry status
NA
Development phase
52
Enrollment target
1
Study location

NCT00602550 is a NA study of HIV Infections that has completed, run by Roxane Laboratories. The registered enrollment target is 52 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00602550, a NA study of HIV Infections, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
NA
Development phase
52 participants
Enrollment target
1
Study location

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

Conditions Studied

Interventions

  • DRUG Zidovudine

Study Locations (1)

Texas

  • CEDRA Clinical Research - Austin

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2003-06
Est. Completion 2003-06
Phase NA

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT00602550

The ClinicalTrials.gov registry entry for NCT00602550 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (88% lower). The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Zidovudine is the first listed.

NCT00602550 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00602550 about?

NCT00602550 is a clinical study titled "Bioequivalency Study of Zidovudine Under Fasting Conditions". 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.

What is the current status of trial NCT00602550?

This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2003-06. Estimated completion is 2003-06.

What conditions does trial NCT00602550 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00602550?

The interventions under investigation include: Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00602550?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00602550 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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