A Randomized, Open, Single-dose, 2x2 Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of A51R1 and A51R2 or Administration of AJU-A51 in Healthy Volunteers Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUCt(Area Under Curve last) of AJU-A51
研究概览
简要总结
To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults
详细描述
This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51.
This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.
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 adults over the age of 19 years at the time of screening
- •Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) < 29.9 kg/m2 and total body weight ≥ 50 kg
- •* BMI = Weight(kg)/ Height(m)2
- •Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
- •Individuals who agreed proper contraception during the study
- •Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
排除标准
- •Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
- •Individuals with an active chronic or acute disease within 1 month.
- •Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
- •Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
- •Individuals with the following medical histories at screening test:
- •T1DM or diabetic ketoacidosis
- •Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- •Renal disorder or pancreatitis etc.
- •A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first
- •Individuals who cannot eat standard meal in institution
- •Women who are pregnant or may be pregnant
- •Individuals who were deemed to be inappropriate to participate in the study by the investigator
研究组 & 干预措施
Sequence A
Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose
干预措施: AJU-A51 Tab. (Drug)
Sequence A
Period 1: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose Period 2: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose
干预措施: A51R1 Tab. and A51R2 Tab. (Drug)
Sequence B
Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose
干预措施: AJU-A51 Tab. (Drug)
Sequence B
Period 1: AJU-A51(FDC tablet, Linagliptin/Dapagliflozin), single dose Period 2: AJU-A51R1 tablet(Dapagliflozin) and AJU-A51R2 tablet(Linagliptin), single dose
干预措施: A51R1 Tab. and A51R2 Tab. (Drug)
结局指标
主要结局
AUCt(Area Under Curve last) of AJU-A51
时间窗: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
Area under the plasma concentration time curve of AJU-A51
Cmax
时间窗: predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72hours post-dose
The maximum concentration observed of AJU-A51 over blood sampling time.
次要结局
未报告次要终点