A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in 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
- Cmax
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 and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.
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 who need to maintain mental alertness throughout the study
- •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
Reference type II
Hydrocodone-Acetaminophen
干预措施: Reference001 type II (Drug)
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
Hydrocodone-Acetaminophen
干预措施: SPARC001 type I (Drug)
Reference001 type I
Hydrocodone-Acetaminophen
干预措施: SPARC001 type II (Drug)
Reference001 type I
Hydrocodone-Acetaminophen
干预措施: Reference001 type I (Drug)
Reference001 type I
Hydrocodone-Acetaminophen
干预措施: Reference001 type II (Drug)
Reference type II
Hydrocodone-Acetaminophen
干预措施: SPARC001 type I (Drug)
Reference type II
Hydrocodone-Acetaminophen
干预措施: SPARC001 type II (Drug)
Reference type II
Hydrocodone-Acetaminophen
干预措施: Reference001 type I (Drug)
结局指标
主要结局
Cmax
时间窗: 48 hours
AUC
时间窗: 48 hours
次要结局
- Adverse event(25 days)