A Randomized, Open-label, Single Dose, 2x2 Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination or Loose Combination of PK101 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs 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)
- •Body weigth ≥50.0kg, 18.5Kg/(m)^2 ≤ (BMI) ≤30.0Kg/(m)^2
- •No congenital or chronic diseases and no abnormal signs determined by medical examinations
- •Not abnormal or not clinical significant lab values
- •Understand the requirements of the study and voluntarily consent to participate in the study.
排除标准
- •Clinically significant disease with liver, renal, neurologic, respiratory, digestive, endocrine, hemato-oncology, urologic, cardiovascular, musculoskeletal, psychiatric system
- •Subjects who have hypersensitivity for investigational products
- •AST or ALT > 2*ULN, r-GTP > 1.5*ULN, Blood creatinine > ULN (ULN, Upper Limit of Normal)
- •SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 90 mmHg or < 60 mmHg
- •Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
- •Subjects who previously participated in other clinical trials or bioequivalence Test within 6 months
- •Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
研究组 & 干预措施
Sequence A
Period 1: PK101-001, PK101-002 / Period 2: PK101
Number of subject: 23
Wash out Period: over 7 days (between each period)
Dosage: Once daily, at 2D each period
干预措施: PK101 (Combination Product)
Sequence A
Period 1: PK101-001, PK101-002 / Period 2: PK101
Number of subject: 23
Wash out Period: over 7 days (between each period)
Dosage: Once daily, at 2D each period
干预措施: PK101-001, PK101-002 (Drug)
Sequence B
Period 1: PK101 / Period 2: PK101-001, P101-002
Number of subject: 23
Wash out Period: over 7 days (between each period)
Dosage: Once daily, at 2D each period
干预措施: PK101 (Combination Product)
Sequence B
Period 1: PK101 / Period 2: PK101-001, P101-002
Number of subject: 23
Wash out Period: over 7 days (between each period)
Dosage: Once daily, at 2D each period
干预措施: PK101-001, PK101-002 (Drug)
结局指标
主要结局
AUCt
时间窗: 0(Pre-dose), 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/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002
Cmax
时间窗: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Maximum Plasma Concentration of PK101-002
次要结局
- CL/F(0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour)
- Tmax(0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour)
- AUCinf(0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour)
- t1/2(0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour)
- AUCt/AUCinf(0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour)