A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
研究概览
简要总结
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
详细描述
Participants were randomly assigned in a 1:1 ratio. TheParticipants 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
- •who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
- •1 administration)
- •Other exclusive criteria, as defined in the protocol
研究组 & 干预措施
Group 1
- Period 1: CKD-383 two tablets(Fed)
- Period 2: CKD-383 two tablets(Fasted)
干预措施: CKD-383(Fed) (Drug)
Group 1
- Period 1: CKD-383 two tablets(Fed)
- Period 2: CKD-383 two tablets(Fasted)
干预措施: CKD-383(Fasted) (Drug)
Group 2
- Period 1: CKD-383 two tablets(Fasted)
- Period 2: CKD-383 two tablets(Fed)
干预措施: CKD-383(Fed) (Drug)
Group 2
- Period 1: CKD-383 two tablets(Fasted)
- Period 2: CKD-383 two tablets(Fed)
干预措施: CKD-383(Fasted) (Drug)
结局指标
主要结局
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
时间窗: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
时间窗: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
次要结局
未报告次要终点