At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches), M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups), and 2 other interventions for Migraine. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups
M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches
Zolmitriptan 2.5 mg/0.1 mL nasal spray \[ZOMIG\] single dose