A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the curve in time plot (AUCt)
研究概览
简要总结
A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112
详细描述
Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult aged 19 and more at the time of screening visit
- •Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
排除标准
- •As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range
- •As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min
研究组 & 干预措施
Treatment A
Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
干预措施: AD-2111 (Drug)
Treatment A
Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
干预措施: AD-2112 (Drug)
Treatment B
Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
干预措施: AD-2111 (Drug)
Treatment B
Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
干预措施: AD-2112 (Drug)
Treatment C
Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
干预措施: AD-2111 (Drug)
Treatment C
Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
干预措施: AD-2112 (Drug)
Treatment D
Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
干预措施: AD-2111 (Drug)
Treatment D
Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
干预措施: AD-2112 (Drug)
Treatment E
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg
干预措施: AD-2111 (Drug)
Treatment E
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg
干预措施: AD-2112 (Drug)
Treatment F
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
干预措施: AD-2111 (Drug)
Treatment F
Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
干预措施: AD-2112 (Drug)
结局指标
主要结局
Area under the curve in time plot (AUCt)
时间窗: pre-dose to 72 hours
AUCt of the total ingredient of Celecoxib, Tramadol
Peak Plasma Concentration (Cmax)
时间窗: pre-dose to 72 hours
Cmax of the total ingredient of Celecoxib, Tramadol
次要结局
- Area under the curve in time plot (AUCinf)(pre-dose to 72 hours)
- Time to reach Cmax(Tmax)(pre-dose to 72 hours)
- Effective half-life(t1/2)(pre-dose to 72 hours)
- Clearance(CL/F)(pre-dose to 72 hours)
- Volume of distribution(Vd/F)(pre-dose to 72 hours)
- Area under the curve in time plot (AUCt) of O-desmethyltramadol(pre-dose to 72 hours)
- Peak Plasma Concentration (Cmax) of O-desmethyltramadol(pre-dose to 72 hours)