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A Drug Interaction Study of the Pharmacokinetics of Flunarizine and Topiramate (RWJ-17021-000) During Mono- and Concomitant Therapy
The primary purpose of this open-label study is to determine if concomitant therapy with topiramate and flunarizine has any effect on the pharmacokinetics of either drug. Safety will be assessed for all subjects, for the entire duration of the study.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 75 |
| Start date | 2003-03 |
| Completion | 2004-03 |
Conditions
- Human Volunteers
- Migraine
Interventions
- Topiramate; flunarizine
Primary outcomes
- For each treatment and each group, the plasma concentration at each time point and the pharmacokinetic parameters of interest will be summarized using descriptive summary statistics.