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NCT00939705 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
A Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00939705: Completed Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
NCT00939705 is a Phase 1 study that has completed, run by Torrent Pharmaceuticals Limited. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00939705, a Phase 1 study, has completed, sponsored by Torrent Pharmaceuticals Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
* Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of adult subjects under fed conditions. * Clinical Design: * Studies were Randomized, Two-Way Crossover, Single-Dose,Open-Label in healthy human adult subjects.
Primary Outcome
The maximum or peak concentration that the drug reaches in the plasma.
Interventions
- DRUG topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Phase | Phase 1 |
What the finished NCT00939705 record still lists
NCT00939705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which topiramate is the first listed.
NCT00939705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00939705 about?
NCT00939705 is a clinical study titled "Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions". * Objective: * Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of adult subjects under fed conditions. * Clinical Desig...
What is the current status of trial NCT00939705?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants.
What interventions are being tested in trial NCT00939705?
The interventions under investigation include: topiramate (DRUG).
Who is sponsoring clinical trial NCT00939705?
This trial is sponsored by Torrent Pharmaceuticals Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00939705's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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