NCT00930215已完成1 期
Open Label, Randomized, Single Center, 2-way Crossover Bioequivalence Study Comparing Gelatine Capsule 40 mg D961H and HPMC Capsule 40 mg D961H After Repeated Oral Administration in Japanese 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
- AstraZeneca
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5
研究概览
简要总结
The purpose of the study is to determine whether the HPMC capsule of D961H 40 mg is bioequivalent to gelatine capsules of D961H 40 mg after a steady state is reached on Day 5
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Healthy Japanese
- •Classified as homo-EM
- •Negative for HIV, Hepatitis B, Hepatitis C and syphilis
排除标准
- •Significant clinical illness from 2 weeks preceding the pre-entry visit to the randomization
- •Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease
研究组 & 干预措施
D961H 40 mg gelatin capsule
Experimental
2 way crossover
干预措施: D961H (Drug)
D961H 40 mg HPMC capsule
Experimental
2 way crossover
干预措施: D961H (Drug)
结局指标
主要结局
Confirm the HPMC capsule of D961H 40 mg is bioequivalent to the gelatin capsule of D961H 40 mg by assessment of area under the plasma concentration-time curve at steady state on Day 5
时间窗: PK sample at Day 5 of treatment period 1 and treatment period 2
次要结局
- Evaluate the PK properties of HPMC capsule of D961H 40 mg following repeated oral doses, by assessment of plasma concentrations, mean residence time, time to maximum plasma concentration and half-life on Day 5(PK sample on Day 5 of treatment period 1 and treatment period 2)
- Evaluate the safety and tolerability of HPMC capsule of D961H 40 mg by assessment of AEs, clinical lab tests, ECG, vital signs.(Pre-entry, Day 5 of treatment period 1 and treatment period 2 and follow up (5-7 days after last dose))
研究者
研究点 (1)
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