An Open-Label, Two-Period, Randomized, Single Oral Dose, Crossover Study to Evaluate the Bioequivalence of Tasimelteon Capsule Formulation Relative to Tasimelteon Liquid Suspension Formulation in Healthy Volunteers
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
- Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
研究概览
简要总结
This is a single center, two-period, randomized study to evaluate the bioequivalence of a single dose of tasimelteon capsule formulation relative to a single dose of liquid suspension formation in healthy volunteers.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female participants between 18 to 55 years (inclusive).
- •Good health as determined by no clinically significant deviations from normal in medical history, clinical laboratory determination, ECGs, and physical examinations conducted during the screening visit.
- •Participants with no clinically significant medical, psychiatric or sleep disorders as determined by the PI.
排除标准
- •Participants with history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- •Participants who suffered from significant physical illness (required hospitalization) in the 4-week period preceding baseline will be excluded.
- •Participants with history of smoking or use of tobacco products in the last 3 months.
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Sequence B
tasimelteon capsule formulation then tasimelteon liquid suspension formulation
干预措施: Tasimelteon Oral Suspension (Drug)
Sequence A
tasimelteon liquid suspension formulation then tasimelteon capsule formulation
干预措施: Tasimelteon Oral Capsule (Drug)
Sequence A
tasimelteon liquid suspension formulation then tasimelteon capsule formulation
干预措施: Tasimelteon Oral Suspension (Drug)
Sequence B
tasimelteon capsule formulation then tasimelteon liquid suspension formulation
干预措施: Tasimelteon Oral Capsule (Drug)
结局指标
主要结局
Bioequivalence between tasimelteon capsule formulation relative to tasimelteon liquid suspension formulation
时间窗: 8 hours
as measured by plasma concentrations
Assessment of Safety and Tolerability of the liquid suspension and capsule formulation of tasimelteon
时间窗: 7 days
as measured by incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs
次要结局
未报告次要终点