NCT03927170已完成1 期
A Randomized, Open-label, Fed, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of GLH1SM Extended Release Tablets in Healthy Volunteers
GL Pharm Tech Corporation1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AUCt in ng·h/mL
研究概览
简要总结
Crossover study to compare the pharmacokinetic characteristics of GLH1SM sustained release tablet and Janumet XR tablet in fed condition
详细描述
2 X 2 crossover study to compare the pharmacokinetic characteristics and safety of GLH1SM sustained release 100/1000mg tablet and Janumet XR 100/1000mg tablet
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects who, at the time of screening, are the age of older than 19 years
- •Subjects who have BMI more than 17.5kg/m2 and less than 30.5kg/m2 and body weight more than 55kg
- •There is no congenital disease or within 3 years of chronic diseases
- •Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG) or clinical laboratory tests
- •Subjects who signed and dated the informed consent form(approved by IRB) after understanding fully to hear a detailed explanation in the clinical trial
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- •A subject with any history of gastrointestinal disease (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which can influence the absorption of investigational products
- •A subject who has the following clinical laboratory test results Liver Function Test (AST, ALT) > two times the upper limit of the normal range
- •History of regular alcohol consumption exceeding 210g/week(12g = 125 mL of wine, 10g = 250 mL of beer, 10g = 50 mL of hard liquor) within 6 months of Screening
- •A subject who has participated in any other clinical trials and had medication within 3 months prior to the first administration of investigational product. (The end date of another clinical trial is based on the last day of the administration)
- •A subject with a history of drug abuse or a positive urine drug screening for drug abuse within 1 year
- •A subject who has taken the drugs that induce and suppress drug- metabolizing enzymes within 30 days prior to investigational product administration
- •A smoker who consumes more than 20 cigarettes/day within 6 months
- •A subject who has taken any ethical-the-counter drug or has taken any over- the-counter drug within 10 days before the investigational product administration
- •A subject who has donated whole blood within 2 months or blood components within 1 month prior to the investigational product administration
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
- •Acute effects that may affect renal function in patients with moderate and severe renal failure (eGFR<45 mL/min/1.73m2) such as sepsis, dehydration, severe infection, cardiovascular collapse, acute myocardial infarction
- •Acute and unstable heart failure
- •Patients receiving intravenous administration of radiation iodine contrast media (eg, intravenous urography, venous cholangiography, angiography, computed tomography using contrast media, etc.)
- •Patients who are known to be hypersensitive to anaphylaxis or angioedema for the drug or its components
- •Patients with acute or chronic metabolic acidosis, including type 1 diabetes, diabetic ketoacidosis with or without coma, and patients with a history of ketoacidosis
- •Patients with severe infectious disease or severe traumatic systemic disorder
- •Abnormal diet that may affect absorption, distribution, metabolism and excretion of drugs
- •Pregnant women, women who may be pregnant, breastfeeding
- •A subject who is not eligible for the study due to reasons on the investigators' judgement
研究组 & 干预措施
GLH1SM tablet 100/1000 mg in FDC
Experimental
GLH1SM tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
干预措施: GLH1SM tablet 100/1000 mg (Combination Product)
Janumet XR tablet 100/1000 mg in FDC
Active Comparator
Janumet XR tablet (Sitagliptin 100 mg and Metformin 1000 mg in Fixed Dose Combination), single dose administration
干预措施: Janumet XR tablet 100/1000 mg (Combination Product)
结局指标
主要结局
AUCt in ng·h/mL
时间窗: 24 hours
Metformin
Cmax in ng/mL
时间窗: 24 hours
Metformin
次要结局
- CL/F in Liter/min/kg(24 hours)
- Vd/F in Liter/kg(24 hours)
- Tmax in hour(24 hours)
- t1/2 in hour(24 hours)
- AUCinf in ng·h/mL(24 hours)
研究者
研究点 (1)
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