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NCT00875784 · ClinicalTrials.gov registry record · Phase 1
An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00875784: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00875784 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00875784, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the exposure of sumatriptan after administration of TREXIMA (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or 6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX 100mg tablet 2 hours later.
Interventions
- DRUG TREXIMA™
- DRUG IMITREX® (4mg)
- DRUG IMITREX® (6mg)
- DRUG IMITREX Tablet 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-05-06 |
| Est. Completion | 2008-06-14 |
| Phase | Phase 1 |
What the finished NCT00875784 record still lists
NCT00875784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which TREXIMA™ is the first listed.
NCT00875784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00875784 about?
NCT00875784 is a clinical study titled "An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)". This study will evaluate the exposure of sumatriptan after administration of TREXIMA (sumatriptan 85mg/naproxen sodium 500mg) followed by a subcutaneous IMITREX injection (4mg or 6mg) 2 hours later compared to administration of a IMITREX 100mg tablet followed by a IMITREX 100mg tablet 2 hours later.
What is the current status of trial NCT00875784?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-05-06. Estimated completion is 2008-06-14.
What interventions are being tested in trial NCT00875784?
The interventions under investigation include: TREXIMA™ (DRUG), IMITREX® (4mg) (DRUG), IMITREX® (6mg) (DRUG), IMITREX Tablet 100mg (DRUG).
Who is sponsoring clinical trial NCT00875784?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00875784's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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