A Phase 1, Randomized, Open‐Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects

• Published in: Headache Vol. 60; no. 4; pp. 701 - 712
• Main Authors: Albrecht, Detlef, Iwashima, Mic, Dillon, Debbie, Harris, Stuart, Levy, Jeff
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.04.2020; John Wiley and Sons Inc
• Subjects: Absorption; Active control; Bioavailability; Confidence intervals; dihydroergotamine; dihydroergotamine mesylate; Dosage; Electrocardiography; Headache; intranasal; Liquid chromatography; Mass spectrometry; Mass spectroscopy; Mathematical analysis; Metabolites; Migraine; Nausea; Pain; Parameters; Pharmacokinetics; Pharmacology; Plasma; Plasma levels; Randomization; Research Submissions; Safety; Signs and symptoms; Variability; pharmacokinetics; intranasal; migraine; dihydroergotamine; dihydroergotamine mesylate

Objective To investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE spray (Migranal®), and intramuscular (IM) DHE injection in healthy subjects. Methods This was a 2‐part, active‐controlled, 3‐peri...