A Randomized, Open-label, Single-dose, Two-way Crossover Bioequivalence Study of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) and Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage® XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) Under Fasting Conditions in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bioequivalence study
研究概览
简要总结
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18.0 to 30.0 kg/m
- •Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.
- •Non-pregnant woman (negative pregnancy test) and not currently breast feeding
- •Female subjects abstain from either hormonal methods of contraception
- •Male subjects who are willing or able to use effective contraceptive
- •Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
排除标准
- •History serious hypersensitivity reactions
- •History or evidence of clinically significant diseases or any significant ongoing chronic medical illness
- •History or evidence of family diabetes
- •History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
- •History or evidence of shock or severe dehydrate or severe infection
- •History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period
- •History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse
- •History of problems with swallowing tablet or capsule
- •History of sensitivity to heparin or heparin-induced thrombocytopenia
- •Any condition possibly affecting drug absorption
- •Have renal creatinine clearance (Clcr) < 45 mL/min based on serum creatinine results at the screening laboratory test
- •12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening
研究组 & 干预措施
Test: Gemigliptin/Metformin
Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg)
干预措施: Gemigliptin tartrate sesquihydrate and metformin (Drug)
Reference: Gemigliptin and Metformin
Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg)
干预措施: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release (Drug)
结局指标
主要结局
bioequivalence study
时间窗: Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00, 32.00 and 48.00 hours post-dose
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions
次要结局
未报告次要终点