Bioequivalency Study of Zidovudine Under Fasting Conditions
Not Applicable
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00602550
- Lead Sponsor
- Roxane Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Bioequivalence Baseline, Two period, Three day washout
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of zidovudine in HIV-1 reverse transcriptase inhibition?
How does zidovudine compare to other NRTIs in first-line HIV treatment regimens?
What biomarkers correlate with zidovudine efficacy in antiretroviral therapy?
What are the common adverse events associated with zidovudine monotherapy in HIV patients?
How does the bioavailability of generic zidovudine compare to branded Retrovir® in clinical practice?
Trial Locations
- Locations (1)
CEDRA Clinical Research
🇺🇸Austin, Texas, United States
CEDRA Clinical Research🇺🇸Austin, Texas, United States