A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUCt of Empagliflozin, sitagliptin, metformin
研究概览
简要总结
This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
详细描述
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 54 years
- •BMI measurement result is 18.0 kg/m2 to 30 kg/m2
- •Written informed consent
- •Other inclusion criteria, as defined in the protocol
排除标准
- •History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
- •AST or ALT or total bilirubin > 1.5 times the upper limit of normal range
- •History of regular alcohol consumption > 21 units/week within 6 months at the time of screening
- •Participated in a clinical trial within 6 months prior to 1st IP dosing
- •Other exclusive inclusion criteria, as defined in the protocol
研究组 & 干预措施
Group 1
- Phase 1: CKD-379 Test drug
- Phase 2: CKD-379 Reference drug
干预措施: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug (Drug)
Group 1
- Phase 1: CKD-379 Test drug
- Phase 2: CKD-379 Reference drug
干预措施: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug (Drug)
Group 2
- Phase 1: CKD-379 Reference drug
- Phase 2: CKD-379 Test drug
干预措施: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug (Drug)
Group 2
- Phase 1: CKD-379 Reference drug
- Phase 2: CKD-379 Test drug
干预措施: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug (Drug)
结局指标
主要结局
AUCt of Empagliflozin, sitagliptin, metformin
时间窗: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
时间窗: 0 hour ~ 48 hour after drug administration
次要结局
- CL/F of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- Tmax of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- t1/2 of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- AUCinf of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- Vd/F of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)