Bioequivalency Study of Zidovudine Under Fed 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 fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

Participation in a clinical trial within 30 days prior to study initiation.
Positive blood screen for HIV or Hepatitis B and C.
History of allergic or adverse responses to zidovudine.

Treatment and study plan

Zidovudine

Drug

Primary outcomes

Bioequivalence

Time frame: Baseline, Two period, Three day washout

Sponsors and collaborators

Lead sponsor

Roxane Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Jan 28, 2008
Registry last updated: Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed