An Open-Label, Randomized, Single-Dose, Two-Period, Two-Way Crossover Comparative Bioavailability Study of Dronabinol Oral Solution, 4.25 mg to Marinol Capsule, 5 mg in Healthy Volunteers Under Fed Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Area under the curve from time 0 to the last measured concentration
研究概览
简要总结
The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.
The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets protocol-specified criteria for qualification
- •Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator
排除标准
- •History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
- •Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- •the analysis of results
研究组 & 干预措施
Group 1 (A,B,C)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.
干预措施: Treatment A (Drug)
Group 1 (A,B,C)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.
干预措施: Treatment B (Drug)
Group 1 (A,B,C)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment B, and then Treatment C.
干预措施: Treatment C (Drug)
Group 2 (B,C,A)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.
干预措施: Treatment A (Drug)
Group 2 (B,C,A)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.
干预措施: Treatment B (Drug)
Group 2 (B,C,A)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment C, and then Treatment A.
干预措施: Treatment C (Drug)
Group 3 (C,A,B)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.
干预措施: Treatment A (Drug)
Group 3 (C,A,B)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.
干预措施: Treatment B (Drug)
Group 4 (C,B,A)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.
干预措施: Treatment C (Drug)
Group 3 (C,A,B)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment A, and then Treatment B.
干预措施: Treatment C (Drug)
Group 4 (C,B,A)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.
干预措施: Treatment A (Drug)
Group 4 (C,B,A)
With a 7-day washout between periods, participants are randomized to receive Treatment C, Treatment B, and then Treatment A.
干预措施: Treatment B (Drug)
Group 5 (A,C,B)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.
干预措施: Treatment A (Drug)
Group 5 (A,C,B)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.
干预措施: Treatment B (Drug)
Group 5 (A,C,B)
With a 7-day washout between periods, participants are randomized to receive Treatment A, Treatment C, and then Treatment B.
干预措施: Treatment C (Drug)
Group 6 (B,A,C)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.
干预措施: Treatment A (Drug)
Group 6 (B,A,C)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.
干预措施: Treatment B (Drug)
Group 6 (B,A,C)
With a 7-day washout between periods, participants are randomized to receive Treatment B, Treatment A, and then Treatment C.
干预措施: Treatment C (Drug)
结局指标
主要结局
Area under the curve from time 0 to the last measured concentration
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Area under the curve extrapolated to infinity
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Maximum plasma concentration
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Time to reach maximum plasma concentration
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination rate constant
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
The time prior to the first measurable (non-zero) concentration
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Elimination half-life
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Apparent oral clearance
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
Volume of distribution
时间窗: 0 hour (predose), 0.08 (5 min), 0.17 (I0 min), 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 8.0, 12, and 16 hours postdose.
次要结局
未报告次要终点