NCT03848637Unknown1 期
A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-375 Tablet With D387 Tablet in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 28
- 主要终点
- Maximum plasma concentration of Empagliflozin
研究概览
简要总结
The purpose of this clinical trial is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-375 and D387 in healthy adults.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 19 to 55 years
- •Females who are not pregnant or breastfeeding or who have surgical infertility
- •Signed informed consent form
- •Other inclusion criteria, as defined in the protocol
排除标准
- •History of clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- •Clinical laboratory test values are outside the accepted normal range at Screening
- •Current smokers or those who cannot quit smoking during the period from 90 days before the first IP dosing to the last discharge.
- •Subject who drink excessive caffeine or alcohol continuously and who cannot discontinue caffeine or alcohol intake during the period from 3 days before the first IP dosing to the last discharge.
- •Participated in a clinical trial within 90 days prior to 1st IP dosing
- •Not eligible to participate for the study at the discretion of Investigator
- •Other exclusive inclusion criteria, as defined in the protocol
研究组 & 干预措施
Group 1
Experimental
- Period 1: D387 (reference drug)
- Period 2: CKD-387 (test drug)
干预措施: CKD-375 (Drug)
Group 1
Experimental
- Period 1: D387 (reference drug)
- Period 2: CKD-387 (test drug)
干预措施: D387 (Drug)
Group 2
Experimental
- Period 1: CKD-387 (test drug)
- Period 2: D387 (reference drug)
干预措施: CKD-375 (Drug)
Group 2
Experimental
- Period 1: CKD-387 (test drug)
- Period 2: D387 (reference drug)
干预措施: D387 (Drug)
结局指标
主要结局
Maximum plasma concentration of Empagliflozin
时间窗: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin
Maximum plasma concentration of Metformin
时间窗: Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Metformin
Area under the plasma concentration of Empagliflozin-time curve from time zero to time of last measurable concentration
时间窗: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Empagliflozin
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
时间窗: Time Frame: 0 hour ~ 48 hour after drug administration
AUClast of Metformin
次要结局
- Area under the plasma concentration of Empagliflozin-time curve from time zero to infinity(0 hour ~ 48 hour after drug administration)
- Area under the plasma concentration of Metformin-time curve from time zero to infinity(0 hour ~ 48 hour after drug administration)
- Time to reach maximum (peak) plasma concentration of Empagliflozin following drug administration(0 hour ~ 48 hour after drug administration)
- Half-life of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Time to reach maximum (peak) plasma concentration of Metformin following drug administration(0 hour ~ 48 hour after drug administration)
- Half-life of Metformin(0 hour ~ 48 hour after drug administration)
- Apparent clearance of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Apparent clearance of Metformin(0 hour ~ 48 hour after drug administration)
- Apparent volume of distribution of Empagliflozin(0 hour ~ 48 hour after drug administration)
- Apparent volume of distribution of Metformin(0 hour ~ 48 hour after drug administration)
研究者
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