Last updated: 11/07/2018 17:39:50
A study to evaluate the pharmacokinetics and tolerability of two single Treximet™ (formerly known as Trexima™) tablets (administered two hours apart) in healthy volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to evaluate the pharmacokinetics and tolerability of two single Treximet™ (formerly known as Trexima™) tablets (administered two hours apart) in healthy volunteers.
Trial description: A study to evaluate the pharmacokinetics and tolerability of two single Treximet™ (formerly known as Trexima™) tablets (administered two hours apart) in healthy volunteers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Wargin B, Alexander WJ, Taylor D, McDonald SA, Lener S, Haberer L. The unique pharmacokinetics of a single tablet combining sumatriptan RT TechnologyTM and naproxen sodium: exposure, effect of food, migraine and a second tablet for the acute treatment of migraine. Presented at: National Headache Foundation’s 3rd Annual Headache Research Summit; February 15-16, 2006; Palm Springs, CA.
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
October 2004 to November 2004
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-13-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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