A Phase I Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCt of Olmesartan
研究概览
简要总结
To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers
详细描述
Pharmacokinetic endpoints
- Primary endpoint : AUCt, Cmax of Dapagliflozin, Olmesartan
- Secondary endpoint : AUC∞, Tmax, t1/2, CL/F, Vd/F of Dapagliflozin, Olmesartan
Safety evaluation
- Adverse reactions (but only in case of TEAE)
- Concomitant drugs
- Vital signs
- Laboratory test
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are over 19 years old at the screening visit
- •Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
- •Those who determined as suitable study subjects by the principal investigator
- •A person who signs the consent form at will, after hearing and understanding a sufficient explanation of the purpose, contents, characteristics of the investigational product, and expected adverse reactions of this clinical trial
排除标准
- •Those who have a clinically significant disease or have a history of such disease
- •Those who have a history of gastrointestinal surgery
- •Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs
- •Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
- •Those who donated whole blood within 2 months or donated components within 2 weeks, or received a blood transfusion within 1 month of the first administration date
研究组 & 干预措施
Sequence A=Reference-Test
T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012
First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose
干预措施: ATB-101, ATB-1011, ATB-1012 (Drug)
Sequence B=Test-Reference
First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose
干预措施: ATB-101, ATB-1011, ATB-1012 (Drug)
结局指标
主要结局
AUCt of Olmesartan
时间窗: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Olmesartan
时间窗: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
AUCt of Dapagliflozin
时间窗: Day1(first stage), Day8(scond stage)
Area under the concentration-time curve
Cmax of Dapagliflozin
时间窗: Day1(first stage), Day8(scond stage)
Maximum concentration of drug in plasma
次要结局
- AUC∞ of Dapagliflozin(Day1(first stage), Day8(scond stage))
- Tmax of Dapagliflozin(Day1(first stage), Day8(scond stage))
- CL/F of Dapagliflozin(Day1(first stage), Day8(scond stage))
- Tmax of Olmesartan(Day1(first stage), Day8(scond stage))
- Vd/F of Dapagliflozin(Day1(first stage), Day8(scond stage))
- AUC∞ of Olmesartan(Day1(first stage), Day8(scond stage))
- CL/F of Olmesartan(Day1(first stage), Day8(scond stage))
- T1/2 of Dapagliflozin(Day1(first stage), Day8(scond stage))
- T1/2 of Olmesartan(Day1(first stage), Day8(scond stage))
- Vd/F of Olmesartan(Day1(first stage), Day8(scond stage))