NCT03849339Unknown1 期
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D635 Under Fed Condition in Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax of Metformin
研究概览
简要总结
The purpose of the clinical trail is to evaluate the pharmacokinetics and safety/tolerability after oral administration of CKD-387 and D635 under fed condition 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 55 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 must be menopause or 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
- •aspartate aminotransferase(AST), alanine aminotransferase(ALT) > 1.25 times the upper limit of the normal range
- •Total Bilirubin > 1.5 times the upper limit of the normal range
- •creatine phosphokinase(CPK) > 1.5 times the upper limit of the normal range
- •estimated Glomerular Filtration Rate(eGFR, MDRD* formula) < 60 mL/min/1.73m2 (*MDRD: Modification of Diet in Renal Disease)
- •Positive reaction on following tests: Hepatitis B, Hepatitis C, human immunodeficiency virus(HIV) and syphilis
- •systolic blood pressure(SBP) ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure(DBP) > 100 mmHg or < 50 mmHg
- •Subject who smoke heavily or drink caffeine or alcohol continuously and who cannot discontinue smoking, caffeine or alcohol intake during hospitalization
- •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: D635
- Period 2: CKD-387
干预措施: CKD-387 (Drug)
Group 1
Experimental
- Period 1: D635
- Period 2: CKD-387
干预措施: D635 (Drug)
Group 2
Experimental
- Period 1: CKD-387
- Period 2: D635
干预措施: CKD-387 (Drug)
Group 2
Experimental
- Period 1: CKD-387
- Period 2: D635
干预措施: D635 (Drug)
结局指标
主要结局
Cmax of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
Maximum plasma concentration of Metformin
AUClast of Metformin
时间窗: 0 hour ~ 48 hour after drug administration
Area under the plasma concentration of Metformin-time curve from time zero to time of last measurable concentration
次要结局
- AUCinf of Metformin(0 hour ~ 48 hour after drug administration)
- Tmax of Metformin(0 hour ~ 48 hour after drug administration)
- t1/2 of Metformin(0 hour ~ 48 hour after drug administration)
- CL/F of Metformin(0 hour ~ 48 hour after drug administration)
- Vd/F of Metformin(0 hour ~ 48 hour after drug administration)
研究者
研究点 (1)
Loading locations...
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