NCT04970940已完成1 期
An Open-label, Multiple Dose, Crossover Study to Evaluate the Drug-drug Interaction Between AJU-A51R1 and AJU-A51R2 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUCτ of AJU-A51R1 and AJU-A51R2
研究概览
简要总结
To evaluate a pharmacokinetic drug interaction between AJU-A51R1 and AJU-A51R2 in healthy male volunteers.
详细描述
This study is to investigate drug-drug interaction between AJU-A51R1 and AJU-A51R2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Individuals whose age is over 19 and under 65 years old when visiting for initial screening test.
- •Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55 kg(men) or 45 kg(women) (Body mass index (BMI) = weight (kg) / height (m)^2) .
- •Individuals with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area.
- •Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
- •The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
- •Individuals who agreed proper contraception during the study
- •The participants must have an ability and willingness to participate throughout the entire trials.
排除标准
- •Individuals with a medical evidence or a history (excluding dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease.
- •Individual who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy).
- •Individual who had following results after examination(a. ALT or AST > twice higher than Upper limit of normal value).
- •Individual Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12g).
- •Individual whose blood pressure < 90 or ≥160(systolic blood pressure) or < 50 or ≥ 100(diastolic blood pressure).
- •Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within 180 days prior to the first dose of this study(except when subject have not taken investigational product(s)).
- •Individual who had a medical history of alcohol and drug abuses.
- •Individual who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug.
- •Individual who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
- •A person who is not determined unsuitable to participate in this test by the researchers.
研究组 & 干预措施
Sequence 1
Experimental
- Period 1: Treatment A(AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days)
- Wash-out for 7 days
- Period 2: Treatment B(AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days)
- Period 3: Treatment C(AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days)
干预措施: Treatment A (Drug)
Sequence 1
Experimental
- Period 1: Treatment A(AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days)
- Wash-out for 7 days
- Period 2: Treatment B(AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days)
- Period 3: Treatment C(AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days)
干预措施: Treatment B (Drug)
Sequence 1
Experimental
- Period 1: Treatment A(AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days)
- Wash-out for 7 days
- Period 2: Treatment B(AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days)
- Period 3: Treatment C(AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days)
干预措施: Treatment C (Drug)
结局指标
主要结局
AUCτ of AJU-A51R1 and AJU-A51R2
时间窗: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose
Area Under Curve tau
Css,max of AJU-A51R1 and AJU-A51R2
时间窗: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours post-dose
Cmax, steady state
次要结局
未报告次要终点
研究者
研究点 (1)
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