An Open-label, Multiple-dosing, Two-arms, One-sequence Study to Evaluate the Safety and Pharmacokinetics After Co-administration of UIC201601 and UIC201602 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Plasma pharmacokinetics(Css,max) of UIC201602
研究概览
简要总结
An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
- •Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
- •Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
- •Subjects able to read and understand a written informed consent, and willing to participate in the study.
排除标准
- •Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
- •Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
- •Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
- •Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
- •Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
研究组 & 干预措施
Treatment A
干预措施: UIC201602 and co-administration of UIC201601 and UIC201602 (Drug)
Treatment B
干预措施: UIC201601 and co-administration of UIC201601 and UIC201602 (Drug)
结局指标
主要结局
Plasma pharmacokinetics(Css,max) of UIC201602
时间窗: 0 hour to 24 hours after Day 14 and Day 49 administration
Maximum concentration of drug in serum at steady state
Plasma pharmacokinetics(AUCss,τ) of UIC201601
时间窗: 0 hour to 24 hours after Day 7 and Day 35
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(AUCss,τ) of UIC201602
时间窗: 0 hour to 24 hours after Day 14 and Day 49 administration
Area under the serum drug concentration-time curve within a dosing interval at steady state
Plasma pharmacokinetics(Css,max) of UIC201601
时间窗: 0 hour to 24 hours after Day 7 and Day 35
Maximum concentration of drug in serum at steady state
次要结局
未报告次要终点