NCT04221360Unknown1 期
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 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
- 26
- 试验地点
- 1
- 主要终点
- AUClast of D390 and CKD-375
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375.
详细描述
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 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 adult who is 19 ~ 55 years at the time of screening
- •Body weight more than 55 kg for male and more than 50kg for female
- •BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
- •Females must be menopause or surgical infertility
- •Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
- •Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
排除标准
- •Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
- •Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
- •Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product
- •Subjects who have a significant urinary tract infection or have such a history
- •Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
- •Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)
- •Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
- •AST, ALT> UNL(Upper Normal Limit)x1.25
- •Total bilirubin > UNL(Upper Normal Limit)x1.5
- •eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
- •Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- •After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
- •Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
- •Pregnant or lactating women
- •Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
- •Subjects who took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator
- •Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug
- •Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
- •Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product
- •Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
- •Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
- •Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
研究组 & 干预措施
Group 1
Experimental
- Period 1: D390
- Period 2: CKD-375
干预措施: CKD-375 (Drug)
Group 1
Experimental
- Period 1: D390
- Period 2: CKD-375
干预措施: D390 (Drug)
Group 2
Experimental
- Period 1: CKD-375
- Period 2: D390
干预措施: CKD-375 (Drug)
Group 2
Experimental
- Period 1: CKD-375
- Period 2: D390
干预措施: D390 (Drug)
结局指标
主要结局
AUClast of D390 and CKD-375
时间窗: 0(predose)~48 hours
Area under the plasma concentration-time curve to last concentration of D390 and CKD-375
Cmax of D390 and CKD-375
时间窗: 0(predose)~48 hours
Maximum plasma concentration of D390 and CKD-375
次要结局
- AUCinf of D390 and CKD-375(0(predose)~48 hours)
- Tmax of D390 and CKD-375(0(predose)~48 hours)
- CL/F of D390 and CKD-375(0(predose)~48 hours)
- t1/2 of D390 and CKD-375(0(predose)~48 hours)
- Vd/F of D390 and CKD-375(0(predose)~48 hours)
研究者
研究点 (1)
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