drugset / Trial / NCT00546650
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
Timeline
- Start
- 2007-11
- Primary completion
- 2007-12
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sumatriptan | Unknown | 6 mg | Other |
| Comparator | Sumatriptan | Unknown | 10 mg | Other |
| Comparator | Sumatriptan | Unknown | 20 mg | Other |
| Comparator | Sumatriptan | Unknown | 100 mg | Other |
Indications
No indication recorded.