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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- DHE Relative Bioavailability
研究概览
简要总结
Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic and safety study.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
STS101 5.2 mg
STS101 (dihydroergotamine nasal powder), 5.2 mg
干预措施: Dihydroergotamine (Drug)
STS101 7.0 mg
STS101 (dihydroergotamine nasal powder), 7.0 mg
干预措施: Dihydroergotamine (Drug)
STS101 8.6 mg
STS101 (dihydroergotamine nasal powder), 8.6 mg
干预措施: Dihydroergotamine (Drug)
DHE intramuscular injection
Dihydroergotamine mesylate
干预措施: Dihydroergotamine (Drug)
DHE nasal spray
Dihydroergotamine mesylate
干预措施: Dihydroergotamine (Drug)
结局指标
主要结局
DHE Relative Bioavailability
时间窗: Pre-dose through 48 hours Post-Dose
The relative bioavailability of STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of dose-corrected Cmax.
DHE Comparative Bioavailability
时间窗: Pre-dose through 48 hours Post-Dose
The comparative bioavailability STS101 5.2, 7.0, and 8.6 mg (test treatments) to 1.0 mg DHE mesylate IM injection (reference treatment) and to 2.0 mg DHE mesylate IN spray (reference treatment) was assessed on the basis of Cmax .
次要结局
- Serious Adverse Events(Pre-dose through 48 hours Post-Dose)
- Treatment-Related Adverse Events(Pre-dose through 48 hours Post-Dose)