A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001 in Healthy, Adult Volunteers Under Fed and Fasted Conditions"
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit;
- •Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight >50 kg (110 lbs) at Screening
- •All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit
- •Medically healthy on the basis of medical history
排除标准
- •Females who are pregnant, lactating, or likely to become pregnant during the study
- •Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder
- •Subjects with history or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease
- •Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
研究组 & 干预措施
SPARC001 type I
Treatment type I
干预措施: SPARC001 type I (Drug)
SPARC001 type I
Treatment type I
干预措施: SPARC001 type II (Drug)
SPARC001 type I
Treatment type I
干预措施: Reference001 type I (Drug)
SPARC001 type I
Treatment type I
干预措施: Reference001 type II (Drug)
SPARC001 type II
Treatment type II
干预措施: SPARC001 type I (Drug)
SPARC001 type II
Treatment type II
干预措施: SPARC001 type II (Drug)
SPARC001 type II
Treatment type II
干预措施: Reference001 type I (Drug)
SPARC001 type II
Treatment type II
干预措施: Reference001 type II (Drug)
Reference001 type I
Treatment type I
干预措施: SPARC001 type I (Drug)
Reference001 type I
Treatment type I
干预措施: SPARC001 type II (Drug)
Reference001 type I
Treatment type I
干预措施: Reference001 type I (Drug)
Reference001 type I
Treatment type I
干预措施: Reference001 type II (Drug)
Reference type II
Treatment type II
干预措施: SPARC001 type I (Drug)
Reference type II
Treatment type II
干预措施: SPARC001 type II (Drug)
Reference type II
Treatment type II
干预措施: Reference001 type I (Drug)
Reference type II
Treatment type II
干预措施: Reference001 type II (Drug)
结局指标
主要结局
AUC
时间窗: 48 hours
Cmax
时间窗: 48 hours
次要结局
- Adverse event(25 days)