NCT04156685已完成1 期
An Open-label, Rendomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-387 in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Part A : Cmax under fasting condition
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-387
详细描述
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-387 in helalthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult older than 19 years and less than 45 years at the time of screening.
- •BMI 18.5~29.9 kg/m2 and body weight more than 50kg.
- •Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to one months after the last investigational product and not to provide sperm for men.
- •Subjects who sign on an informed consent form willingly.
排除标准
- •Subjects who have a clinically significant disease or medical history such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nervous and mental disease.
- •Subjects who have acute disease within 28 days prior to the first administration.
- •Subjects who have history that may affect the ADME.
- •Subjects who have medical history or medical abuse history of hypersensitivity from SGLT inhibitors or Biguanides including Metformin or other medications(Aspirin, Antibiotics etc.).
- •Subjects who have clinically significant chronic disease.
- •Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption.
- •Subjects whose laboratory test result are same as below;
- •AST,ALT > UNL(Upper Normal Limit)x3
- •Fasting glucose level out of 70-125mg/dl
- •Creatinine clearance is lower than 80mL/min which is calcuated by Cockcroft-Gault formulation.
- •QT>450msec
- •Positive urine hCG(female).
- •Subjects whoes blood pressure exceeds out of normal range as below at screening.
- •SBP : over 100mmHg, under 160mmHg
- •DBP : over 60mmHg, under 100mmHg
- •Subjects who have been found to be positive in serological tests(HBs antigen, HCV antibody and HIV antibody).
- •Subjects who took ETC(Ethical Drug), oriental medicine within 2 weeks prior to the first administration of investigational products.
- •Subjects who took OTC(Over-the-counter Drug, including korean galenical drug) within 10 days prior to the first administration of investigational products.
- •Subjects who have allergic disease which has clinical significance(But, light allergic rhinitis and ligth allergic dermatitis which do not need medication is exceptional).
- •Subjects who can not eat standard meals provided by the institution.
- •Subjects who donated whole blood within 60 days, donated the blood components within 20 days prior to the first administration of investigational products.
- •Subjects who received blood transfusion within 30 days prior to the first administration of investigational products.
- •Subjects who were participated in the other clinical trial within 90 days prior to the first administration of investigational products.
- •Subjects who took medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 6months prior to the first administration of investigational products.
- •Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days prior to the first administration of investigational products. (Ingestion of grapefruit juice>1L/day or Caffein>5Cups/day).
- •Subjects who have took regular alcohol(alcohol>30g/day) prior to the first administration of investigational products.
- •Subjects who smoked more than 10 cigarettes per day prior 3months to the first administration of investigational products or cannot discontinue smoking during the clinical trial.
- •Subjects who is determined unsuitable to participate in this clinical trial by the investigator.
- •Lactating Women.
研究组 & 干预措施
PartA, Treatment-1
Experimental
Period 1 : Reference drug Period 2 : Test drug
干预措施: Part A, Reference (D635 10/500mg, Astrazeneca) (Drug)
PartA, Treatment-2
Experimental
Period 1 : Test drug Period 2 : Reference drug
干预措施: Part A, Reference (D635 10/500mg, Astrazeneca) (Drug)
PartB, Treatment-1
Experimental
Period 1 : Reference drug Period 2 : Test drug
干预措施: Part B, Reference (D635 10/500mg, Astrazeneca) (Drug)
PartB, Treatment-2
Experimental
Period 1 : Test drug Period 2 : Reference drug
干预措施: Part B, Reference (D635 10/500mg, Astrazeneca) (Drug)
结局指标
主要结局
Part A : Cmax under fasting condition
时间窗: 0(predose)~48 hours
Maximum concentration of the metformin
Part B : Cmax under fed condition
时间窗: 0(predose)~48 hours
Maximum concentration of the metformin
Part B : AUClast under fed condition
时间窗: 0(predose)~48 hours
Area Under Curve(last) of the metformin
Part A : AUClast under fasting condition
时间窗: 0(predose)~48 hours
Area Under Curve(last) of the metformin
次要结局
- Part B : AUCinf under fed condition(0(predose)~48 hours)
- Part A : AUCinf under fasting condition(0(predose)~48 hours)
- Part A : t1/2 under fasting condition(0(predose)~48 hours)
- Part A : Tmax under fasting condition(0(predose)~48 hours)
- Part B : Tmax under fed condition(0(predose)~48 hours)
- Part B : t1/2 under fed condition(0(predose)~48 hours)
研究者
研究点 (1)
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