Bioequivalency Study of Zidovudine Under Fed Conditions
Not Applicable
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00601562
- 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 fed 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 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.
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 molecular mechanisms of zidovudine influence its bioequivalence in HIV treatment?
How does zidovudine compare to other NRTIs in managing HIV under fed conditions?
Which biomarkers correlate with zidovudine efficacy in HIV-infected patients?
What adverse events are associated with zidovudine in HIV treatment and how are they managed?
How do combination therapies with zidovudine impact HIV viral load and resistance profiles?
Trial Locations
- Locations (1)
CEDRA Clinical Research, LLC
🇺🇸Austin, Texas, United States
CEDRA Clinical Research, LLC🇺🇸Austin, Texas, United States