A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers

Migraine Clinical Trial

Official title: A Randomized Open-label Four-way Crossover Study of Pharmacokinetics, Safety, and Tolerability of 3 Formulations of M207 3.8 mg on the Upper Arm for 30 Minutes With Intranasal Zolmitriptan 2.5 mg in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs ~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.

Clinical Trial Description

This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis.

Dosing will occur approximately 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized.

After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study. ;

Related Conditions & MeSH terms

• Migraine

• NCT number: NCT03978403
• Study type: Interventional
• Source: Zosano Pharma Corporation
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2019
• Completion date: June 28, 2019