Loading clinical trials...

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) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests.
•Female subjects of non-childbearing potential
•Any subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening.
•BMI: 20-30 kg/m2, inclusive.
•Subject is willing and able to provide written informed consent.

Exclusion Criteria

•Subjects who suffer from migraine attacks.
•Subject has confirmed or suspected ischemic heart disease; angina pectoris, history of myocardial infarction, documented silent ischemia, Prinzmetal's angina-coronary vasospasm, signs, or symptoms consistent with any of the above.
•Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's syndrome.
•Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
•Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
•Subject has a history of congenital heart disease.
•Subject has hypertension at screening.
•Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
•Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
•History of impaired hepatic or renal function.
+17 more criteria

Locations (1)

GSK Investigational Site

Tacoma, Washington, United States

Key Dates

Start Date

May 6, 2008

Primary Completion Date

June 14, 2008

Completion Date

June 14, 2008

Last Updated

August 4, 2017

Enrollment

ACTUAL participants

Conditions

Migraine Disorders

Interventions

TREXIMA™

DRUG

IMITREX® (4mg)

DRUG

IMITREX® (6mg)

DRUG

IMITREX Tablet 100mg

DRUG

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

View study

RECRUITING

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

NCT05570149

Migraine Disorders

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Mind Body Balance for Pediatric Migraine

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

Tai Chi for the Prophylaxis of Episodic Migraine: the Efficacy Examination and Mechanism Exploration

Valproate Versus Propranolol in Migraine

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

Potential Osteocatabolic Effect Caused by Anti-CGRP mAbs in Migraine Patients Treated With Anti-CGRP mAbs - an Observational Pilot Project With Prospectively Collected Health Related Data