Lead Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Age

18 - 68 years

Sex

ALL

Healthy Volunteers

No

•Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
•Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
•Female subjects required to be adequately protected against pregnancy.

•pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
•Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
•Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
•Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.