Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
Public ClinicalTrials.gov record NCT00648466. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single-Dose Fasting In Vivo Bioequivalence Study of Sumatriptan Succinate Tablets (100 mg; Mylan) to Imitrex® Tablets (100 mg; GlaxoSmithKline) in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00648466
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 55 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2004
- Primary completion
- Nov 30, 2004
- Completion
- Nov 30, 2004
- Last update posted
- Nov 30, 2009
2004
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00648466, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 30, 2009 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00648466 live on ClinicalTrials.gov.