NCT04013477已完成1 期
A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults
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
- 40
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 Male Volunteers (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
Cohort1
Experimental
drug : DA-5207 80mg/40cm²
placebo : 40cm²
干预措施: DA-5207 (Drug)
Cohort2
Experimental
drug : DA-5207 120mg/60cm²
placebo : 60cm²
干预措施: DA-5207 (Drug)
Cohort3
Experimental
drug : DA-5207 160mg/80cm²
placebo : 80cm²
干预措施: DA-5207 (Drug)
Cohort4
Active Comparator
drug : Aricept
干预措施: Donepezil Hydrochloride (Drug)
结局指标
主要结局
Cmax
时间窗: patch : 21days, oral : 11days
maximum serum concentration
AUC
时间窗: patch : 21days, oral : 11days
area under the concentration-time curve
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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