NCT03394482已完成1 期
Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- AUC0-72h of Lu AF35700
研究概览
简要总结
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
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 men and women aged ≥18 and ≤55 years
- •Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
- •Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination
排除标准
- •The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
- •The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
- •The subject has previously been dosed with Lu AF35700
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AF35700 5 mg clinical formulation
Experimental
干预措施: Lu AF35700 5 mg clinical formulation (Drug)
Lu AF35700 5 mg commercial formulation
Experimental
干预措施: Lu AF35700 5 mg commercial formulation (Drug)
Lu AF35700 10 mg clinical formulation
Experimental
干预措施: Lu AF35700 10 mg clinical formulation (Drug)
Lu AF35700 10 mg commercial formulation
Experimental
干预措施: Lu AF35700 10 mg commercial formulation (Drug)
Lu AF35700 20 mg clinical formulation
Experimental
干预措施: Lu AF35700 20 mg clinical formulation (Drug)
Lu AF35700 20 mg commercial formulation
Experimental
干预措施: Lu AF35700 20 mg commercial formulation (Drug)
结局指标
主要结局
AUC0-72h of Lu AF35700
时间窗: zero to 72 hours
Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Cmax of Lu AF35700
时间窗: zero to 72 hours
Maximum observed plasma concentration (Cmax) of Lu AF35700
次要结局
- AUC0-t of Lu AF35700(zero to time of the last quantifiable plasma concentration)
- Tmax of Lu AF35700(zero to 72 hours)
研究者
研究点 (1)
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