Evaluation of the Pharmacokinetics and Safety of Dihydroergotamine Administered Via Two Intranasal Delivery Devices

Phase 1

Completed

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000330640
• Lead Sponsor: Impax Laboratories, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Healthy male and female subjects between 18 years and 40 years of age inclusive at the time of Screening

Exclusion Criteria

Presence of a clinically significant disorder including acute or chronic infections, or a malignant neoplasm, and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators

An upper respiratory tract infection or any other acute illness, including active allergic rhinitis, at Screening or at Check-in for each treatment period that the investigator believes may interfere with the administration, nasal retention, or absorption of study drug; or any prior medical conditions that, in the opinion of the Investigator, would interfere or modify the nasal administration, retention, or absorption of study drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified