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)

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 6, 2008

Primary Completion Date

June 14, 2008

Study Completion Date

June 14, 2008

Conditions
Migraine Disorders
Interventions
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

Trial Locations (1)

98418

GSK Investigational Site, Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY