An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet...
Date First Received: October 4, 2006
Last Updated: December 18, 2007
Verified by: Pozen, December 2007
Clinical Trial Phase: Phase 1 | Start Date: September 2006
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
Official Title: “An Open Label, Single Dose, Parallel Group Study to Evaluate Absorption and Transit Characteristics of TREXIMA and RELPAX in Patients Inside and Outside of an Acute Migraine Attack.”
Condition Keyword(s):
An evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a TREXIMA tablet and eletriptan from a RELPAX 40mg tablet.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Bio-availability Study
Outcome Measures for this Clinical Trial
Primary:
- tablet disintegration, transit throught the gastrointestinal tract, pharmacokinetic parameters both during a migraine and when not experiencing a migraine
Secondary:
- safety and adverse experiences
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Consented males and nonpregnant females using adequate contraception, between 18 and 55 years of age, with at least 1-6 migraines per month for past 6 months. Subjects will be excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. Other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10 cigarettes/day, evidence of alcohol or substance abuse; GI bleeding disorders, inflammatory bowel disease; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Pozen
Scintipharma, Inc.
Lexington Kentucky 40503 United States
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00385008
Study ID Number: TRX105848
ClinicalTrials.gov Identifier: NCT00385008
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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