Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
研究概览
简要总结
An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged between 19 and 65 years, clinically healthy
- •BMI between 18.5kg/m2 and 27kg/m2
- •Clinical history of Androgenic Alopecia
排除标准
- •Subject has any dermatological disorders of the scalp
- •Subject has a history of hair transplants, hair weaves
- •Subject has hypersensitivity to previously prescribed minoxidil or finasteride
- •Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion
研究组 & 干预措施
Sequence A
Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
干预措施: DA-4001 H (Drug)
Sequence A
Period 1: DA-4001 H(High dose) Period 2: DA-4001 L(Low dose)
干预措施: DA-4001 L (Drug)
Sequence B
Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
干预措施: DA-4001 H (Drug)
Sequence B
Period 1: DA-4001 L(Low dose) Period 2: DA-4001 H(High dose)
干预措施: DA-4001 L (Drug)
结局指标
主要结局
Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
时间窗: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
时间窗: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Change from baseline of testosterone and DHT(ng/mL)
时间窗: day1: before administration, day7: before administration and 6, 12, 24h after administration
次要结局
- Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)(day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration)
- Css,min(Minimum steady state concentration)of Finasteride(ng/mL)(day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration)
- t1/2β(Elimination Half-life) of Finasteride(hr)(day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration)