Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 44
- 主要终点
- Gemigliptin and dapagliflozin AUClast and Cmax
研究概览
简要总结
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
详细描述
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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 who are 19 years ~ 50 years when they are screened
- •weight: 55.0 kg ~ 90.0 kg and BMI: 18.0 kg/m2 ~ 30.0 kg/m2
- •Volunteers who understand the procedures of clinical trial and signed informed consent form
- •Volunteers who are eligible decided by vital signs, physical examination, lab test and 12-lead ECG
- •Women of chlidbearing potential have negative results in pregnancy test
排除标准
- •Healtjy volunteers who don't have clinically significant disease such as liver disease, severe renal disease, acute pancreatitis... etc
- •Drug Allergy in aspirin, NSAID, Anti-bacterial drugs
- •GI tract diseases which affect PK results and safety such as ulceritis, GERD, chron disease...
- •Chronic urine track infection
- •Allergy history in sunset yellow 5 pigment and Fast green FCF (pigment)
- •galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •These resluts are appeared when screening
- •ALT, AST >= 1.5 Upper limit of normal range
- •HbsAg, anti-HCV, HIV Ag&Ab positive
- •MDRD equation: eGFR< 60 mL/min/1.73m2
- •QTcB> 450 ms
- •Fasting serum glucose < 70mg/dL or >110mg/dL
- •HbA1c>6.5%
- •SBP<90mmHg or >150mmHg, DBP <60mmHg or >100mmHg
研究组 & 干预措施
Arm I
Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
干预措施: Zemiglo 50mg and Forxiga 10mg (Drug)
Arm I
Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
干预措施: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg (Drug)
Arm II
Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
干预措施: Zemiglo 50mg and Forxiga 10mg (Drug)
Arm II
Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg
干预措施: Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg (Drug)
结局指标
主要结局
Gemigliptin and dapagliflozin AUClast and Cmax
时间窗: Day 1 72hour
each phase 17 times blood sampling, total 34 times blood sampling
次要结局
- Gemigliptin and dapagliflozin CL/F(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin metabolite(LC15-0636) AUClast(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin metabolite(LC15-0636) t1/2(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin and dapagliflozin AUCinf(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin and dapagliflozin V/F(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin and dapagliflozin Tmax(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin metabolite(LC15-0636) metabolic ratio(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin and dapagliflozin t1/2(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin metabolite(LC15-0636) Cmax(Pre-dose (Day1 0 h), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)
- Gemigliptin metabolite(LC15-0636) AUCinf(Pre-dose (Day1 0 hour), Day 1 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour)