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NCT00601562 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Zidovudine Under Fed Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT00601562: Completed NA study, sponsored by Roxane Laboratories.
NCT00601562 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601562, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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.
Interventions
- DRUG Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2003-06 |
| Est. Completion | 2003-06 |
| Phase | NA |
What the finished NCT00601562 record still lists
NCT00601562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.
NCT00601562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601562 about?
NCT00601562 is a clinical study titled "Bioequivalency Study of Zidovudine 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.
What is the current status of trial NCT00601562?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2003-06. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00601562?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00601562?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00601562's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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