A Randomized, Open Label, Single Oral Dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg and Coadministration of Gemigliptin 50 mg and Dapagliflozin/Metformin 10/1000 mg in Healthy Adults in Fed Condition
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The plasma concentration of gemigliptin, dapagliflozin, and metformin
研究概览
简要总结
Bioequivalence study for the fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg under fed conditions 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-50 years in healthy volunteers
- •18.0 kg/m^2 ≤ BMI ≤ 29.9 kg/m^2, 50kg ≤weight ≤ 90kg
- •60≤ FPG≤125 mg/dL
- •Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial.
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system.
- •Subjects with clinically significant abnormal findings during tests (or examinations)
- •Subjects with a history of hypersensitivity or clinically significant hypersensitivity reactions to test drugs or other drugs
- •Subjects judged ineligible by the investigator
研究组 & 干预措施
Sequence A
Sequence A: Test drug -> Reference drug
干预措施: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Sequence A
Sequence A: Test drug -> Reference drug
干预措施: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg (Drug)
Sequence B
Sequence B: Reference drug -> Test drug
干预措施: Test drug: Fixed-dose combination (FDC) of gemigliptin/dapagliflozin/metformin 50/10/1000 mg (Drug)
Sequence B
Sequence B: Reference drug -> Test drug
干预措施: Reference drug: gemigliptin (Zemiglo) 50mg, Xigduo XR 10/1000 mg (Drug)
结局指标
主要结局
The plasma concentration of gemigliptin, dapagliflozin, and metformin
时间窗: - Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration
Primary Parameters: Area under the plasma concentration versus time curve (AUClast) of gemigliptin, dapagliflozin, and metformin
次要结局
- The plasma concentration of gemigliptin, dapagliflozin and metformin(- Period 1: 16 times up to 72 hours from IP administration - Period 2: 16 times up to 72 hours from IP administration)
- The plasma concentration of gemigliptin, dapagliflozin and metformin(Period 1: 16 times up to 72 hours from IP administration Period 2: 16 times up to 72 hours from IP administration)