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Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults

Migraine Clinical Trial

Official title:
A Phase 1 First in Human Open-Label Study of the Safety and Pharmacokinetics of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults

Clinical Trial Summary

This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in adult healthy volunteers.

Clinical Trial Description

Objectives:

- To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427 (zolmitriptan inhalation powder) in healthy adults, with special emphasis on cardiopulmonary effects.

- To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig® Tablet, and Zomig® Nasal Spray in healthy adults. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02609945
Study type Interventional
Source Acorda Therapeutics
Contact
Status Completed
Phase Phase 1
Start date November 2015
Completion date April 2016
View Details
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