Last updated: 11/07/2018 01:31:44
An open-label, randomized, 2-way crossover study evaluating sumatriptan pharmacokinetics following single oral doses of Trexima and sumatriptan 100mg RT tablets 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: An open-label, randomized, 2-way crossover study evaluating sumatriptan pharmacokinetics following single oral doses of Trexima and sumatriptan 100mg RT tablets in healthy volunteers
Trial description: An open-label, randomized, 2-way crossover study evaluating sumatriptan pharmacokinetics following single oral doses of Trexima and sumatriptan 100mg RT tablets 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:
Byrd S, Guillard F, Lener S, Kori S, Walls C, Haberer L. Early sumatriptan pharmacokinetics following a sumatriptan 100mg RT Technology™ tablet and a fixed single-tablet formulation of sumatriptan 85mg RT Technology™ and naproxen sodium 500mg. Presented at: National Headache Foundation’s 4th Annual Headache Research Summit; February 13, 2007; Palm Springs, CA.
Kori S, Derosier F, Walls C, Guilliard F, Haberer L, Lener S, Byrd S. PK and Cardiovascular Effects of a Single Tablet of Sumatriptan RT 85mg/Naproxen Sodium 500mg vs Sumatriptan RT 100mg. Cephalalgia 2007; Vol 27:724.
Walls C, Byrd S, Hickmott F, Lener S, Kori S, Ochs-Ross R, Haberer L. Early sumatriptan pharmacokinetics following a sumatriptan 100mg RT Technology™ tablet and a fixed single-tablet formulation of sumatriptan 85mg RT Technology™ and 500mg naproxen sodium. Cephalalgia 2006;26 (Suppl 11);1395 (Abs No PE.18)
Medical condition
Migraine Disorders
Product
sumatriptan
Collaborators
Not applicable
Study date(s)
February 2006 to March 2006
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
2006-18-03
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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