A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.

36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 5-period crossover manner.

Inclusion Criteria:

• 18 to 50 years of age at the time of enrollment.
• Signed the informed consent document.
• Subject judged to be healthy by a qualified physician

Exclusion Criteria:

• Abnormal physical findings of clinical significance at the screening examination
• Significant abnormal laboratory values at the Screening Visit.
• Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.