drugset / Trial / NCT04969497
Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis. Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.
Timeline
- Start
- 2021-06-24
- Primary completion
- 2021-09-02
- Completion
- 2021-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | M207 | Unknown | 3.8 mg | Other |
| Subject | Zolmitriptan | Small molecule | 5 mg | Intranasal |