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NCT00939692 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
A Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00939692: Completed Phase 1 study, sponsored by Torrent Pharmaceuticals Limited.
NCT00939692 is a Phase 1 study that has completed, run by Torrent Pharmaceuticals Limited. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00939692, a Phase 1 study, has completed, sponsored by Torrent Pharmaceuticals Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 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 26 adult subjects under fasted 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 | 26 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
What the finished NCT00939692 record still lists
NCT00939692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Topiramate is the first listed.
NCT00939692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00939692 about?
NCT00939692 is a clinical study titled "Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted 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 26 adult subjects under fasted conditions. * Clinical...
What is the current status of trial NCT00939692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2007-01. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00939692?
The interventions under investigation include: Topiramate (DRUG).
Who is sponsoring clinical trial NCT00939692?
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 NCT00939692's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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