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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)

NCT00875784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-04

No results posted yet for this 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.

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-06
Primary Completion
2008-06-14
Completion
2008-06-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00875784 on ClinicalTrials.gov