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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00875784
The ClinicalTrials.gov registry entry for NCT00875784 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which TREXIMA™ is the first listed.
NCT00875784 reports 0 study locations.
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.
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