Bioequivalency Study of Zidovudine Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00601562
First received: September 19, 2007
Last updated: February 7, 2008
Last verified: February 2008

September 19, 2007
February 7, 2008
June 2003
June 2003   (final data collection date for primary outcome measure)
Bioequivalence [ Time Frame: Baseline, Two period, Three day washout ] [ Designated as safety issue: No ]
Bioequivalence [ Time Frame: Baseline, Two period, Three day washout ]
Complete list of historical versions of study NCT00601562 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Zidovudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601562
ZIDO-04
No
Elizabeth Ernst, Director, Drug Regulatory Affairs and Medical Affairs, Roxane Laboratories, Inc.
Roxane Laboratories
Not Provided
Principal Investigator: Daniel V Freeland, DO CEDRA Clinical Research
Roxane Laboratories
February 2008

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