drugset / Trial / NCT00989625
A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
RandomizedParallel-groupOpen-labelOther
Summary
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60mg naproxen sodium, 30mg sumatriptan/180mg naproxen sodium, 85mg sumatriptan/500mg naproxen sodium) in adolescent migraine patients. The same doses will be also administered to a group of healthy volunteer (HV) adult subjects and the PK parameters will be compared between these two groups and between doses.
Timeline
- Start
- 2008-11-04
- Primary completion
- 2009-09-10
- Completion
- 2009-09-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Naproxen | Small molecule | 60 mg | — |
| Comparator | Naproxen | Small molecule | 180 mg | — |
| Comparator | Naproxen | Small molecule | 500 mg | — |
| Comparator | Sumatriptan | Unknown | 10 mg | — |
| Comparator | Sumatriptan | Unknown | 30 mg | — |
| Comparator | Sumatriptan | Unknown | 85 mg | — |