Bioequivalency Study of Zidovudine Under Fasting Conditions - Full Text View

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00602550

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 fasting 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 Fasting 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 physical exam, medical history, or clinical laboratory findings during screening.

Exclusion Criteria:

Allergic or adverse responses to zidovudine or any other comparable or similar products.
Participation in clinical trial within 30 days of study initiation.
Positive blood screen for HIV, Hepatitis B and C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602550

Locations

United States, Texas
CEDRA Clinical Research
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-03
Study First Received:	September 19, 2007
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00602550
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
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 January 14, 2009