A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax of Dapagliflozin
研究概览
简要总结
Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg 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 volunteers between the ages of 19 and 55
- •Body weight ≥ 55kg for male, ≥ 50kg for female
- •Body mass index ≥ 18.5 kg/m2 and < 25.0 kg/m2
- •Females who are post-menopausal or underwent sterilization
- •Males who agreed to practice contraception until after 28 days of last intake Investigational product
- •Ability to provide written informed consent
排除标准
- •Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
- •Subject who are weak in dehydration or clinically significant dehydration
- •IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
- •Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
- •Hypersensitive to dapagliflozin/metformin
- •At screening,
- •AST(Aspartate Transaminase), ALT(Alanine Transaminase) > UNL(upper normal limit)*1.25
- •Total Bilirubin > UNL(upper normal limit)*1.5, CPK > UNL(upper normal limit)*1.5
- •eGFR(estimated Glomerular Filtration Rate) < 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
- •Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
- •SBP(Systolic blood pressure) ≥ 150 mmHg or < 90 mmHg, DBP(Diastolic blood pressure) > 100 mmHg or < 50 mmHg
- •History of drug abuse or positive urine drug screening results
- •Women with pregnant, breast-feeding
- •Caffeine > 5 cups/day, Alcohol > 210 g/week, Smoker > 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
- •Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
- •Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
- •Subject with whole blood donation within 60 days or component blood donation within 30 days
- •Not eligible to participate for the study at the discretion of Investigator
研究组 & 干预措施
Group 1
Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)
干预措施: CKD-387 (Drug)
Group 1
Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387)
干预措施: D484 (Drug)
Group 2
Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)
干预措施: CKD-387 (Drug)
Group 2
Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484)
干预措施: D484 (Drug)
结局指标
主要结局
Cmax of Dapagliflozin
时间窗: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Maximum plasma concentration of Dapagliflozin
Cmax of Metformin
时间窗: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Maximum plasma concentration of Metformin
AUClast of Dapagliflozin
时间窗: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
AUClast of Metformin
时间窗: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Area under the plasma concentration-time curve to last concentration of Metformin
次要结局
- AUCinf of Dapagliflozin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- AUCinf of Metformin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- Tmax of Dapagliflozin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- Vd/F of Dapagliflozin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- CL/F of Metformin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- T1/2 of Dapagliflozin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- Tmax of Metformin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- T1/2 of Metformin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- Vd/F of Metformin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)
- CL/F of Dapagliflozin(Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration)