A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Area Under the Concentration-time Curve
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.
详细描述
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian male 19-55 years of age.
- •Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- •Medically healthy with no clinically significant medical history.
- •Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
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 90/60 mmHg or greater than 140/90 mmHg at screening.
- •Plasma donation within 7 days prior to the first dose of study drug.
- •Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
研究组 & 干预措施
Sequence 3 (BAC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 1 (ABC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 1 (ABC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 1 (ABC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
Sequence 2 (ACB)
Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 2 (ACB)
Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 2 (ACB)
Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
Sequence 3 (BAC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 3 (BAC)
Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
Sequence 4 (BCA)
Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 4 (BCA)
Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 4 (BCA)
Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
Sequence 5 (CAB)
Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 5 (CAB)
Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 5 (CAB)
Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
Sequence 6 (CBA)
Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan (Drug)
Sequence 6 (CBA)
Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Rosuvastatin (Drug)
Sequence 6 (CBA)
Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)
There will be a washout of at least 7 days between the each period.
干预措施: Fimasartan + Rosuvastatin (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve
时间窗: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Maximum Observed Concentration
时间窗: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.
Time to Reach Maximum Observed Plasma Concentration
时间窗: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the time it takes a drug to reach Cmax
次要结局
未报告次要终点