A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 (1000/10mg) in Healthy Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cmax of Metformin and rosuvastatin
研究概览
简要总结
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male 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 50 kg, The result of Body Mass Index(BMI) is not less than 18.0 kg/m2 , no more than 29.0 kg/m
- •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.
- •100 mmHg ≥ Systolic BP ≥ 150mmHg or 55 mmHg ≥ Diastolic BP ≥ 95 mmHg
- •AST or ALT > X 2 UNL
- •Total bilirubin > 2.0 mg/dL
- •CK > X 2 UNL
- •eGFR < 60 mL/min/1.73m2
- •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
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
干预措施: "Metformin" and "Rosuvastatin" seperately (Drug)
Group I
Period I: administration of "Metformin" and "Rosuvastatin" seperately Period II: JLP-1310
干预措施: JLP-1310 (Drug)
Group II
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
干预措施: "Metformin" and "Rosuvastatin" seperately (Drug)
Group II
Period I: JLP-1301 Period II: administration of "Metformin' and "Rosuvastatin" seperately
干预措施: JLP-1310 (Drug)
结局指标
主要结局
Cmax of Metformin and rosuvastatin
时间窗: 48 hours
AUCt of Metformin and rosuvastatin
时间窗: 48 hours
次要结局
未报告次要终点