An Open Label, Randomized, Single-dose, 4-period Cross-over Study to Compare the Pharmacokinetics and Safety Following Administration of JLP-1401 and Coadministration of Rosuvastatin and Telmisartan/Amlodipine in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The PK Characteristics of the Co-administration of Rosuvastatin and Telmisartan/Amlodipine and JLP-1401 in Healthy Male Volunteers 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
- •Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •Subject who has the ability and willingness to participate the whole period of trial
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •Subjects who are allergic to investigational drug.
- •Subjects who have a medical history which can affect the clinical trial.
- •Systolic BP > 140mmHG or Diastolic BP > 90mmHg)
- •AST or ALT > X 2 UNL
- •History of drug abuse or positive drug screening.
- •Participation in other drug studies within 3 months prior to the drug administration.
- •Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
研究组 & 干预措施
Group I (JLP-1401)
JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)
干预措施: JLP-1401 (Drug)
Group I (JLP-1401)
JLP-1401(Telmisartan 80 mg, amlodipine 10 mg, rosuvastatin 20 mg)
干预措施: Telmisartan/Amlodipine, Rosuvastatin (Drug)
Group II(Telmisartan/Amlodipine, Rosuvastatin)
Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)
干预措施: JLP-1401 (Drug)
Group II(Telmisartan/Amlodipine, Rosuvastatin)
Twinsta(Telmisartan 40 mg, amlodipine 5 mg) 2 tab and Crestor(rosuvastatin 20 mg)
干预措施: Telmisartan/Amlodipine, Rosuvastatin (Drug)
结局指标
主要结局
AUC
时间窗: 72hr after baseline
Area under the curve of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
Cmax
时间窗: 72 after baseline
Peak concentration of telmisartan, amlodipine, rosuvastatin at 72 hours after baseline
次要结局
未报告次要终点