A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- AUCτ and Cmax,ss of D961H
研究概览
简要总结
This study is to investigate whether D961H sachet 20 mg is bioequivalent to D961H HPMC capsule 20 mg following repeated oral doses, and to evaluate the safety and tolerability of these two formulations in healthy male Japanese subjects.
详细描述
A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Bioequivalence Study Comparing a Pellets Based Sachet Formulation of D961H 20 mg and a Commercial HPMC Capsule of D961H 20 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Japanese healthy male subjects aged 20 to 45 years of age
- •Body Mass Index 19-27 kg/m2 and body weight 50-85 kg
- •Clinically normal findings
- •Classified as homo-EM(extensive metabolizers) according to the genotype of CYP2C19
排除标准
- •Significant clinical illness
- •Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
- •Clinical significant condition which could modify the absorption of the investigational product
- •Past or present severe allergic disease, hypersensitivity to food or drugs, or allergic symptoms requiring medical intervention
研究组 & 干预措施
D961H Sachet 20 mg
2 way crossover
干预措施: D961H Sachet 20 mg (Drug)
D961HHPMC Capsule 20 mg
2 way crossover
干预措施: D961H HPMC capsule 20 mg (Drug)
结局指标
主要结局
AUCτ and Cmax,ss of D961H
时间窗: Day 5
* AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration * Cmax,ss - maximum concentration at steady state
次要结局
- Profile of pharmacokinetic of D961H in terms of AUC0-t,ss, MRT, tmax,ss, and t1/2.(Day 5)
- Safety and tolerability of a D961H in terms of clinical laboratory tests, blood pressure, pulse rate and body temperature.(Up to 5 to 7 days after the last dose.)
- Number of participants with adverse events.(Up to 5 to 7 days after the last dose.)