An Open Label, 6-sequence, 3-period Study to Evaluate Drug-drug Interactions and Safety Between "BR3006-1", "BR3006-2", and "BR3006-3" in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- AUCτ,ss
研究概览
简要总结
The purpose of this clinical trial is to evaluate drug-drug interactions and safety between "BR3006-1", "BR3006-2", and "BR3006-3" in healthy volunteers
详细描述
A total of 36 subjects will be randomized into 6 sequence groups, 6 subjects per sequence group. The Investigational Products wil be according to the treatment group (A,B,C,D,E,F) assigned to each sequence group in Period 1, Period 2 and Period 3.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of screening test, those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.5 to 30.0 kg/m
- •Those who voluntarily decide to participate in the study after listening to and fully understanding the detailed explanation of this study and provide written consent prior to the screening procedure.
排除标准
- •Those who have clinically significant diseases associated with the liver, kidney, gastrointestinal system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, blood/tumor system, cardiovascular system, severe infection, severe traumatic systemic disorder, etc.
- •Those who have a medical history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative disease, etc.) or gastrointestinal surgery (however, appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids•anal fissure•anal fistula surgery are excluded) that may affect the absorption of drugs.
- •Those who have participated in another clinical study within 180 days prior to the first administration date.(However, the termination criteria for participation in previous clinical trials is counted as one day after the date of the last administration)
- •Those who take any prescription drugs(including herbal medicines) or any over-the-counter (OTC) drugs within 14 days prior to the first day of administration or who disagree with the prohibition about taking it from within 14 days prior to the first day of administration to the end of the study (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
- •Those who have taken a food (e.g., grapefruit juice, etc.) or health functional foods that may affect the absorption, distribution, metabolism, and excretion of the drug within 3 days prior to the first day of administration or cannot stop taking it from within 3 days prior to the first day of administration to the end of the study.
- •Those who do not agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (except for hormone drugs) accepted in clinical trial from the date of the first administration of the investigational product to 7 days after the last administration or disagrees to provide their sperm or ovum
- •Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
- •Those who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •Pregnant women, breast-feeding women or those positive in a pregnancy test.
研究组 & 干预措施
Treatment 1(T1)
BR3006-1 + BR3006-2 administered in combination once daily for 7 days.
干预措施: BR3006-1 (Drug)
Treatment 1(T1)
BR3006-1 + BR3006-2 administered in combination once daily for 7 days.
干预措施: BR3006-2 (Drug)
Treatment 2(T2)
BR3006-3 administered alone once daily for 7 days.
干预措施: BR3006-3 (Drug)
Treatment 3(T3)
BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.
干预措施: BR3006-1 (Drug)
Treatment 3(T3)
BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.
干预措施: BR3006-2 (Drug)
Treatment 3(T3)
BR3006-1 + BR3006-2 + BR3006-3 administered in combination once daily for 7 days.
干预措施: BR3006-3 (Drug)
结局指标
主要结局
AUCτ,ss
时间窗: Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period
Area under the concentration-time curve from time zero to time τ of BR3006-1, BR3006-2 and BR3006-3 at steady-state
Cmax,ss
时间窗: Day 1 (0h), Day 5 (0h), Day 6 (0h), Day 7 (0h~14h) & Day 8 (0h), Day 9 (0h), Day 10 (0h) of each period
Maximum concentration of drug in plasma of BR3006-1, BR3006-2 and BR3006-3 at steady-state
次要结局
未报告次要终点