Bioequivalency Study of Zidovudine Under Fed Conditions - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Zidovudine

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

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

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:

Bioequivalence [ Time Frame: Baseline, Two period, Three day washout ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	June 2003
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601562

Locations


United States, Texas
	CEDRA Clinical Research, LLC
	Austin, Texas, United States, 78759

Sponsors and Collaborators

Roxane Laboratories

Investigators


Principal Investigator:	Daniel V Freeland, DO	CEDRA Clinical Research

More Information

Responsible Party:	Roxane Laboratories, Inc. ( Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs )
Study ID Numbers:	ZIDO-04
First Received:	September 19, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00601562
Health Authority:	United States: Food and Drug Administration

Keywords provided by Roxane Laboratories:

HIV

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Malnutrition

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00601562