Back to resultsBioequivalency Study of Zidovudine Under Fasting Conditions
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV
Eligibility 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.
Sites / Locations
- CEDRA Clinical Research
Outcomes
Primary Outcome Measures
Bioequivalence
Secondary Outcome Measures
Full Information
NCT ID
NCT00602550
First Posted
September 19, 2007
Last Updated
January 19, 2018
Sponsor
Roxane Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00602550
Brief Title
Bioequivalency Study of Zidovudine Under Fasting Conditions
Official Title
A Single Dose, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalency Study of 300 mg Zidovudine Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Roxane Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Primary Outcome Measure Information:
Title
Bioequivalence
Time Frame
Baseline, Two period, Three day washout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel V Freeland, DO
Organizational Affiliation
CEDRA Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEDRA Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioequivalency Study of Zidovudine Under Fasting Conditions
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