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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 35 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649467
The ClinicalTrials.gov registry entry for NCT00649467 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Topiramate Sprinkle Capsules 25 mg is the first listed.
NCT00649467 reports 0 study locations.
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.
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