A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Cross-over Design Clinical Trial to Evaluate the Safety and Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- ATB-1012 AUCτ,ss,
研究概览
简要总结
To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.
详细描述
- Arm A: To evaluate the effect of ATB-1012 on the safety and pharmacokinetic properties of ATB-1011 in steady state.
- Arm B: To evaluate the effect of ATB-1011 on the safety and pharmacokinetic properties of ATB-1012 in steady state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Those who are over 19 years old at the screening visit
- •Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit
- •Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit
- •Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product.
排除标准
- •Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.
- •Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
研究组 & 干预措施
Arm A
ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days
干预措施: Olmesartan (Drug)
Arm A
ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days
干预措施: Dapagliflozin (Drug)
Arm B
ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days
干预措施: Olmesartan (Drug)
Arm B
ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
ATB-1012 AUCτ,ss,
时间窗: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1011 AUCτ,ss
时间窗: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1011 Cmax,ss
时间窗: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
ATB-1012 Cmax,ss
时间窗: 5days, 10days
the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties.
次要结局
- ATB-1012 Tmax,ss(5days, 10days)
- ATB-1012 Cmin,ss(5days, 10days)
- ATB-1011 Tmax,ss(5days, 10days)
- ATB-1011 Cmin,ss(5days, 10days)