Phase 1 Study to Evaluate the Safety and the Pharmacokinetics of GC2129A in Healthy Adult Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetic (PK) parameters - Cmax
研究概览
简要总结
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
详细描述
This study is an open-label, randomized, fasting, single-dose, 2-group, 2-period, crossover design to evaluate pharmacokinetics that are not affected by blinding. According to the order of administering the investigational drug for each period, 25 people are assigned to each of the two groups and administered.
For healthy subjects, each 25 subjects are assigned to each of the two groups(total 50 subjects). If the subject administrate GC2129A in the first stage, the subject will be administrated reference drugs in the second stage after washout(over 7 weeks). Conversely, if the subject administrate reference drugs in the first stage, the subject will be administrated with GC2129A in the second stage.
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
- •A person who is 19 years of age or older at the time of a screening visit
- •A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit
- •A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination
排除标准
- •Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology.
- •A person who has a history of gastrointestinal surgery
- •Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date
- •A person who participates in another clinical trial or biological equivalence test within six months of the first administration date
- •A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks
- •A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria
- •In the case of female volunteers, a pregnant woman or pregnant woman is suspected
研究组 & 干预措施
GC2129A + Reference drugs
Period 1: GC2129A Period 2: Individual Components
干预措施: GC2129A(Period 1) (Drug)
GC2129A + Reference drugs
Period 1: GC2129A Period 2: Individual Components
干预措施: Linaglptin 5mg and Metformin Hydrochloride 1000mg(Period 2) (Drug)
Reference drugs + GC2129A
Period 1: Individual Components Period 2: GC2129A
干预措施: Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1) (Drug)
Reference drugs + GC2129A
Period 1: Individual Components Period 2: GC2129A
干预措施: GC2129A(Period 2) (Drug)
结局指标
主要结局
Pharmacokinetic (PK) parameters - Cmax
时间窗: 0-72hours
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
Pharmacokinetic (PK) parameters - AUCt
时间窗: 0-72hours
Pharmacokinetic (PK) parameters of Linagliptin and Metformin in serum
次要结局
- Pharmacokinetic (PK) parameters - t1/2(0-72hours)
- Pharmacokinetic (PK) parameters - AUCinf(0-72hours)
- Pharmacokinetic (PK) parameters - Tmax(0-72hours)