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NCT00648934 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00648934 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 36 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00648934, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
Conditions Studied
Interventions
- DRUG Topiramate Sprinkle Capsules 25 mg
- DRUG Topamax® Sprinkle Capsules 25 mg
Study Locations (1)
West Virginia
- Kendle International Inc. - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-11 |
| Est. Completion | 2005-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648934
The ClinicalTrials.gov registry entry for NCT00648934 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (94% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Topiramate Sprinkle Capsules 25 mg is the first listed.
NCT00648934 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT00648934 about?
NCT00648934 is a clinical study titled "Fed 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 capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
What is the current status of trial NCT00648934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2005-11. Estimated completion is 2005-12.
What conditions does trial NCT00648934 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00648934?
The interventions under investigation include: Topiramate Sprinkle Capsules 25 mg (DRUG), Topamax® Sprinkle Capsules 25 mg (DRUG).
Who is sponsoring clinical trial NCT00648934?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00648934 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.