A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
详细描述
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male 19-50 years of age.
- •Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
- •Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
- •Medically healthy with no clinically significant medical history.
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
- •Plasma donation within a month prior to the first dose of study drug.
- •Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
研究组 & 干预措施
Sequence B
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)
There will be a washout of 35 days between the each period.
干预措施: Treatment B (Fimasartan/Linagliptin) (Drug)
Sequence A
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)
There will be a washout of 35 days between the each period.
干预措施: Treatment A (Fimasartan, Linagliptin) (Drug)
Sequence A
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)
There will be a washout of 35 days between the each period.
干预措施: Treatment B (Fimasartan/Linagliptin) (Drug)
Sequence B
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)
There will be a washout of 35 days between the each period.
干预措施: Treatment A (Fimasartan, Linagliptin) (Drug)
Sequency C
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)
There will be a washout of 35 days between the each period.
干预措施: Treatment A (Fimasartan, Linagliptin) (Drug)
Sequency C
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)
There will be a washout of 35 days between the each period.
干预措施: Treatment B (Fimasartan/Linagliptin) (Drug)
结局指标
主要结局
Cmax
时间窗: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast
时间窗: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin
次要结局
未报告次要终点