An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health Voulunterrs (Age : 19~55 years)
- •Body Weight : Male≥55kg, Female≥50kg
- •18.5 ≤BMI≤ 25.0
排除标准
- •Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
- •Allergy or Drug hypersensitivity
- •Clinically significant Medical History
- •AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
- •Heavy alcohol intake (more than 210g/week)
- •Heavy smoker (more than 10 cigarettes/day)
- •Heavy caffeine intake
研究组 & 干预措施
Sequence 2
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
干预措施: DA-5207 150mg (Drug)
Sequence 1
Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: Aricept 5mg Tablet (Drug)
Sequence 1
Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: Aricept 10mg Tablet (Drug)
Sequence 1
Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: DA-5207 150mg (Drug)
Sequence 2
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
干预措施: Aricept 5mg Tablet (Drug)
Sequence 2
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
干预措施: Aricept 10mg Tablet (Drug)
Sequence 3
Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: Aricept 5mg Tablet (Drug)
Sequence 3
Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: Aricept 10mg Tablet (Drug)
Sequence 3
Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
干预措施: DA-5207 170mg (Drug)
Sequence 4
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
干预措施: Aricept 5mg Tablet (Drug)
Sequence 4
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
干预措施: Aricept 10mg Tablet (Drug)
Sequence 4
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
干预措施: DA-5207 170mg (Drug)
结局指标
主要结局
AUC
时间窗: 29-36 days
area under the concentration-time curve
Css,max
时间窗: 0-36 days
maximum serum concentration at steady state
次要结局
未报告次要终点