A Randomized, Open Labeled, Multiple Dose, 2-Sequence, 2-Period Cross-over Phase 1 Study to Evaluate the Drug-Drug Interaction of PK101-001 and PK101-002 in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Cmax,ss
研究概览
简要总结
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults ≥ 19 years of age (on the day of screening)
- •No congenital or chronic diseases and no abnormal signs determined by medical examinations
- •Not abnormal or not clinical significant lab values
- •90mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg
- •18Kg/(m)^2 ≤ (BMI) ≤30Kg/(m)^2
排除标准
- •Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
- •Subjects who were administered medications of prohibition within 10 days
- •Heavy drinking within 30 days (female: over 14units/week, male:over 21units/week)
- •Heavy smoker within 30 days (over 20 cigarettes per day)
- •Subjects who previously participated in other clinical trials or bioequivalence Test within 90 days
- •Subjects who donated whole blood within 60 days or donated component blood within 14 days or received blood transfusion within 30 days
- •Subjects who have hypersensitivity for investigational products
研究组 & 干预措施
Sequence (1)
Number of Subject: 24
Wash out Period: over 7 days (between each period)
Investigators Products(IPs) for Period1: A (Single)= PK101-002
IPs for Period2: B (Combination)= PK101-001, PK101-002
干预措施: PK101-002 (Drug)
Sequence (1)
Number of Subject: 24
Wash out Period: over 7 days (between each period)
Investigators Products(IPs) for Period1: A (Single)= PK101-002
IPs for Period2: B (Combination)= PK101-001, PK101-002
干预措施: PK101 (Combination Product)
Sequence (2)
Number of Subject: 24
Wash out Period: over 7 days (between each period)
IPs for Period1: B (Combination)= PK101-001, PK101-002
IPs for Period2: A (Single)= PK101-002
干预措施: PK101-002 (Drug)
Sequence (2)
Number of Subject: 24
Wash out Period: over 7 days (between each period)
IPs for Period1: B (Combination)= PK101-001, PK101-002
IPs for Period2: A (Single)= PK101-002
干预措施: PK101 (Combination Product)
结局指标
主要结局
Cmax,ss
时间窗: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
The maximum (or peak) serum concentration for PK101-002 at Steady-state
AUCτ
时间窗: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
次要结局
未报告次要终点