A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cmax of Lobeglitazone, Empagliflozin, Metformin
研究概览
简要总结
This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state
详细描述
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 65 years
- •Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
- •within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
- •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 A
- Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)
- Phase 2: CKD-383 2 tablets(Test)
干预措施: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG (Drug)
Group B
- Phase 1: CKD-383 2 tablets(Test)
- Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)
干预措施: Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG (Drug)
结局指标
主要结局
Cmax of Lobeglitazone, Empagliflozin, Metformin
时间窗: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
AUCt of Lobeglitazone, Empagliflozin, Metformin
时间窗: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
次要结局
- Vd/F of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
- CL/F of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
- AUC∞ of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
- Tmax of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)
- T1/2 of Lobeglitazone, Empagliflozin, Metformin(0 hour ~ 48 hour after drug administration)