A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUClast of abiraterone
研究概览
简要总结
Study Design : A randomized, open-label, four-sequence, four-period, crossover, single dosing, phase 1 study
详细描述
To evaluate the safety, tolerability and pharmacokinetic characteristics of SOL-804-F and Zytiga tablets following a single oral dose and Zytiga 1,000 mg in healthy male volunteers.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy adult male volunteers between 19 to 50 years of age at screening visit.
- •Body mass index (BMI) between 19.0 to 30.0 kg/m2
- •The subjects voluntarily decide to participate in the study after receiving a full explanation and understanding and provide written consent
- •The subjects are suitable for this study as determined by the investigator (physical examination, clinical laboratory tests, etc.)
排除标准
- •Clinically significant abnormal physical examination, vital signs or ECG
- •The subjects who have a medical history of hepatobiliary, renal, neurological, immune, respiratory, endocrine, hematologic, oncologic, cardiovascular, urinary, psychiatric or sexual dysfunction.
- •The subjects who have a hereditary disorder including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •The subjects who have a history of drug abuse or positive with urine drug screening test
研究组 & 干预措施
Group 1
Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
干预措施: SOL-804-F (Drug)
Group 1
Period 1: Zytiga® 1000mg / Period 2 : SOL-804-F 302.5mg / Period 3 : SOL-804-F 242.0mg / Period 4 : SOL-804-F 181.5mg
干预措施: Zytiga (Drug)
Group 2
Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
干预措施: SOL-804-F (Drug)
Group 2
Period 1 : SOL-804-F 181.5mg / Period 2 : Zytiga® 1000mg / Period 3 : SOL-804-F 302.5mg / Period 4 : SOL-804-F 242.0mg
干预措施: Zytiga (Drug)
Group 3
Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
干预措施: SOL-804-F (Drug)
Group 3
Period 1 : SOL-804-F 242.0mg / Period 2 : SOL-804-F 181.5mg / Period 3 Zytiga® 1000mg / Period 4 : SOL-804-F 302.5mg
干预措施: Zytiga (Drug)
Group 4
Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg
干预措施: SOL-804-F (Drug)
Group 4
Period 1 : SOL-804-F 302.5mg / Period 2 : SOL-804-F 242.0mg / Period 3 : SOL-804-F 181.5mg / Period 4 : Zytiga® 1000mg
干预措施: Zytiga (Drug)
结局指标
主要结局
AUClast of abiraterone
时间窗: 72 hours
Area under the plasma drug concentration-time curve from 0 to last
Cmax of abiraterone
时间窗: 72 hours
The maximum or peak concentration between zero and dosing interval
次要结局
- Tmax of abiraterone(72 hours)
- t1/2 of abiraterone(72 hours)
- AUCinf of abiraterone(72 hours)
- Vd/F of abiraterone(72 hours)
- CL/F of abiraterone(72 hours)