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NCT00650247 · ClinicalTrials.gov registry record · Phase 1
Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT00650247: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00650247 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 57 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650247, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
Conditions Studied
Interventions
- DRUG Sumatriptan Succinate Tablets 100 mg
- DRUG Imitrex® Tablets 100 mg
Study Locations (1)
West Virginia
- Kendle International Inc. - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2004-11 |
| Est. Completion | 2004-12 |
| Phase | Phase 1 |
What the finished NCT00650247 record still lists
NCT00650247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Sumatriptan Succinate Tablets 100 mg is the first listed.
NCT00650247 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT00650247 about?
NCT00650247 is a clinical study titled "Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg". The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
What is the current status of trial NCT00650247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2004-11. Estimated completion is 2004-12.
What conditions does trial NCT00650247 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00650247?
The interventions under investigation include: Sumatriptan Succinate Tablets 100 mg (DRUG), Imitrex® Tablets 100 mg (DRUG).
Who is sponsoring clinical trial NCT00650247?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650247 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00650247's enrollment target sits among peer trials
57 410th of 1090 higher than 679 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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