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 120mg/Atorvastatin 40mg and Co-administration of Fimasartan 120mg and Atorvastatin 40mg in Healthy Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.
详细描述
This is a randomized, open-label, single dose, 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/Atorvastatin and co-administration of Fimasartan and Atorvastatin.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A Healthy male aged 19-50 years
- •Body weight is over 55kg and BMI 18 ~ 27(kg/m2).
- •A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
- •A subject who is eligible according to investigator's assessment
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •History of gastrointestinal disease and resection
- •Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
- •Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
- •A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
- •Positive results for serum examination(HIV, B and C viral test, Syphilis).
- •Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
- •Participation in any other study within 3months.
- •History of whole blood donation within 2months and Apheresis 2 weeks.
研究组 & 干预措施
A fixed dose combination group
A fixed dose combination of Fimasartan/Atorvastatin
干预措施: Fimasartan, Atorvastatin (Drug)
Co-administration group
Co-administration of Fimasartan and Atorvastatin
干预措施: Fimasartan, Atorvastatin (Drug)
结局指标
主要结局
Cmax(Maximum concentration of drug in plasma) of Fimasartan, Atorvastatin
时间窗: 0~48 hours after medication
AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Fimasartan, Atorvastatin
时间窗: 0~48 hours after medication
次要结局
未报告次要终点