A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy subjects
详细描述
This is an open-label, randomized, crossover study to evaluate the pharmacokinetics and safety. Within each period, randomized subjects will be take 2 dosing regimens that BR9001 or BR900A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 19-50 years of age
- •Body mass index (BMI) ≥ 18.5 and ≤ 27.0 kg/m^2 at screening
- •Medically healthy with no clinically significant medical history
- •No clinically significant result with laboratory test including chemistry, serum, urine test within 3 weeks in prior to administration of investigational product
- •Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol
排除标准
- •History or presence of clinically significant medical or psychiatric condition or disease.
- •Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Creatinint clearance < 80 mL/min (using Cockcroft-Gault) at screening.
- •Whole blood donation within a 2 months prior to the first dose of study drug.
- •Participation in another clinical trial or bioequivalence study within 12 weeks prior to the first dose of study drug(s).
研究组 & 干预措施
Sequence 1
BR900A - Wash out - BR9001
干预措施: BR900A (Drug)
Sequence 2
BR9001 - Wash out - BR900A
干预措施: BR900A (Drug)
Sequence 2
BR9001 - Wash out - BR900A
干预措施: BR9001 (Drug)
Sequence 1
BR900A - Wash out - BR9001
干预措施: BR9001 (Drug)
结局指标
主要结局
AUClast
时间窗: 0-24 hours after administration
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of BR9001 and BR900A
Cmax
时间窗: 0-24 hours after administration
Maximum concentration of drug in plasma of BR9001 and BR900A
次要结局
未报告次要终点