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NCT00648466 · ClinicalTrials.gov registry record · Phase 1
Fasting 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
- 55
- Enrollment target
- 1
- Study location
NCT00648466 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 55 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.
The verdict
NCT00648466, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 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 administration under fasting 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 | 55 participants |
| Start Date | 2004-11 |
| Est. Completion | 2004-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00648466
The ClinicalTrials.gov registry entry for NCT00648466 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 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 (91% 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 Sumatriptan Succinate Tablets 100 mg is the first listed.
NCT00648466 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT00648466 about?
NCT00648466 is a clinical study titled "Fasting 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 administration under fasting conditions.
What is the current status of trial NCT00648466?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2004-11. Estimated completion is 2004-12.
What conditions does trial NCT00648466 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00648466?
The interventions under investigation include: Sumatriptan Succinate Tablets 100 mg (DRUG), Imitrex® Tablets 100 mg (DRUG).
Who is sponsoring clinical trial NCT00648466?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00648466 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
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