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Bioequivalency Study of Zidovudine Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00601562
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : January 23, 2018
Information provided by:
West-Ward Pharmaceutical

September 19, 2007
January 28, 2008
January 23, 2018
June 2003
June 2003   (Final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, Two period, Three day washout ]
Same as current
Complete list of historical versions of study NCT00601562 on ClinicalTrials.gov Archive Site
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Bioequivalency Study of Zidovudine Under Fed Conditions
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets 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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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2003
June 2003   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
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Principal Investigator: Daniel V Freeland, DO CEDRA Clinical Research
West-Ward Pharmaceutical
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP