Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 48
- 主要终点
- Gemigliptin AUC
研究概览
简要总结
To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.
详细描述
To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 19~45
- •Body weight: 55kg or higher(female: 50kg or higher) and BMI 18~27kg/m2
- •SBP 90~150mmHg, DBP 60-95mmHg
- •Fasting glucose 70~120mg/dL
- •Infertility
- •Surgically infertile
- •To prevent pregnancy, participants who agreed using 2 or more contraceptive methods. Such as
- •Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide
- •Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring
- •Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena)
- •Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
- •People who perfectly understood clinical trial and independently decided to participate in clinical trial.
- •People who will be able to collect blood sample during clinical trial period.
- •People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview.
排除标准
- •Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption
- •Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc.
- •People who have gastrointestinal disease or history of surgery which would affect absorption of drug.
- •History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease
研究组 & 干预措施
monolayer group
monolayer of Gemigliptin/Rosuvastatin
干预措施: Monolayer group (Drug)
monolayer group
monolayer of Gemigliptin/Rosuvastatin
干预措施: Bilayer group (Drug)
bilayer group
bilayer of Gemigliptin/Rosuvastatin
干预措施: Bilayer group (Drug)
bilayer group
bilayer of Gemigliptin/Rosuvastatin
干预措施: Monolayer group (Drug)
结局指标
主要结局
Gemigliptin AUC
时间窗: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
Rosuvastain AUC
时间窗: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
Rosuvastain Cmax
时间窗: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Rosuvastain
Gemigliptin Cmax
时间窗: 0hour(pre-dose), 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour
Gemigliptin
次要结局
未报告次要终点