An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cmax of Dutasteride and Tamsulosin.
研究概览
简要总结
To evaluate and compare the safety and pharmacokinetic profiles of "AJU-G721" (test drug) and "G721R" (reference drug) in healthy adult male subjects.
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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged ≥19 years and <55 years at screening.
- •Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m².
- •Clinically healthy based on medical history, physical examination, ECG, and laboratory test results, as determined by the investigator.
- •Willing and able to provide written informed consent.
- •Agrees to use medically acceptable contraception during the required study period.
排除标准
- •Use of medications known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or other medications that may interfere with the study within 10 days prior to dosing.
- •Participation in another clinical trial involving an investigational product within 6 months prior to the first dose.
- •Whole blood donation within 8 weeks or component blood donation within 2 weeks prior to the first dose.
- •History of gastrointestinal resection that may affect drug absorption.
- •Known hypersensitivity to dutasteride, tamsulosin, or any component of the investigational product.
- •History of psychiatric illness, or any condition considered unsuitable for study participation by the investigator.
研究组 & 干预措施
Sequence A
Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
干预措施: Test Drug (Drug)
Sequence A
Period 1: Reference Drug, Single dose/ Period 2: Test Drug, Single dose
干预措施: Reference Drug (Drug)
Sequence B
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
干预措施: Test Drug (Drug)
Sequence B
Period 1: Test Drug, Single dose/ Period 2: Reference Drug, Single dose
干预措施: Reference Drug (Drug)
结局指标
主要结局
Cmax of Dutasteride and Tamsulosin.
时间窗: [Time Frame: 0 hour ~ 72 hour after drug administration]
To assess the maximum observed plasma concentration (Cmax) of Dutasteride and Tamsulosin.
AUCt of Dutasteride and Tamsulosin
时间窗: [Time Frame: 0 hour ~ 72 hour after drug administration]
To assess the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dutasteride and Tamsulosin
次要结局
未报告次要终点