Trials / Completed
CompletedNCT00875784
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)
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) Injection 4mg Administered Using the IMITREX STATdose System® and a TREXIMA Tablet Followed by IMI
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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) Injection 4mg administered using the IMITREX STATdose System® and a TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® compared with an IMITREX Tablet 100mg followed by an IMITREX Tablet 100mg.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TREXIMA™ | sumatriptan succinate / naproxen sodium tablet |
| DRUG | IMITREX® (4mg) | sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® |
| DRUG | IMITREX® (6mg) | sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® |
| DRUG | IMITREX Tablet 100mg | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
Timeline
- Start date
- 2008-05-06
- Primary completion
- 2008-06-14
- Completion
- 2008-06-14
- First posted
- 2009-04-03
- Last updated
- 2017-08-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00875784. Inclusion in this directory is not an endorsement.