NCT02523391已完成1 期
A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged 18-55
- •Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive
排除标准
- •Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
- •Subject has any other condition which, in the Investigator's opinion will interfere with the study.
- •Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
研究组 & 干预措施
Treatment Period 1
Experimental
Either 5mg TA-8995 Capsule or Tablet
干预措施: TA-8995 (Drug)
Treatment Period 2
Experimental
Either 5mg TA-8995 Capsule or Tablet
干预措施: TA-8995 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
时间窗: 72 hours
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
时间窗: 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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