A Randomized, Open-label, Single-dose, Two-way Crossover, Phase 1 Trial to Evaluate Bioequivalence of "LCB01-0371(Batch#1650006)" and "LCB01-0371(Batch#3183817R)" in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)
研究概览
简要总结
The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A person who is a healthy adult aged between 19 and 45 years old with the result of BMI between 18.0 kg/m2 and 28.0 kg/m2
- •A healthy adult whose weight is over 50 kg
- •A person who is deemed suitable for a clinical trial subject in physical examination, vital sign tests, diagnostic examination, and 12-lead ECG by the medical doctor, etc.
排除标准
- •A person who has a clinically significant history of the disease, such as liver, kidney, gastrointestinal disease, respiratory tract disease, muscular-skeletal disease, endocrine disease, nervous system disease, blood ∙ tumor disease, cardiovascular disease, etc.
- •A person who has a history of gastrointestinal diseases or surgery that may affect the absorption of IP, etc.
研究组 & 干预措施
Group A
Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
干预措施: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) (Drug)
Group A
Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)
干预措施: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) (Drug)
Group B
Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)
干预措施: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) (Drug)
Group B
Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)
干预措施: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) (Drug)
结局指标
主要结局
Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast)
时间窗: 0-12hours
Area under the plasma concentration curve from zero until the last measurable concentration
Pharmacokinetic evaluation: The observed maximum concentration(Cmax)
时间窗: 0-12hours
Pharmacokinetic parameters will be assessed using non-compartmental method
次要结局
- Pharmacokinetic evaluation: Time to reach Cmax(Tmax)(0-12hours)
- Pharmacokinetic evaluation: Elimination half-life(t1/2)(0-12hours)
- Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F)(0-12hours)
- Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F)(0-12hours)
- Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf)(0-12hours)