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NCT00649467 · ClinicalTrials.gov registry record · Phase 1
Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT00649467: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT00649467 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649467, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.
Interventions
- DRUG Topiramate Sprinkle Capsules 25 mg
- DRUG Topamax® Sprinkle Capsules 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2005-11 |
| Est. Completion | 2005-12 |
| Phase | Phase 1 |
What the finished NCT00649467 record still lists
NCT00649467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Topiramate Sprinkle Capsules 25 mg is the first listed.
NCT00649467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00649467 about?
NCT00649467 is a clinical study titled "Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg". The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.
What is the current status of trial NCT00649467?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2005-11. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00649467?
The interventions under investigation include: Topiramate Sprinkle Capsules 25 mg (DRUG), Topamax® Sprinkle Capsules 25 mg (DRUG).
Who is sponsoring clinical trial NCT00649467?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00649467's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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