NCT03098940Unknown1 期
A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers
Axim Biotechnologies0 个研究点目标入组 50 人开始时间: 2018年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 主要终点
- Bioequivalence
研究概览
简要总结
This study is a two part study
详细描述
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions
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
- •Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.
排除标准
- 未提供
研究组 & 干预措施
Chewing gum
Experimental
Chewing gum with various doses of dronabinol
干预措施: Chewing Gum (Drug)
Capsule (Marinol)
Active Comparator
Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol
干预措施: Chewing Gum (Drug)
结局指标
主要结局
Bioequivalence
时间窗: up to 48 hours post-dose
based on Area under the plasma concentration versus time curve (AUC)
次要结局
未报告次要终点
研究者
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