A Phase IV, Comparative, Randomized, Double Blind, Single-Dose, 2-way Crossover Study to Evaluate the Pharmacokinetics and Safety of Alpharma Branded Products Division (KADIAN)and Ligand Pharmaceuticals Inc. (Avinza) 30 mg Morphine Sulfate Sustained-Release Capsules in Healthy Adult Volunteers Under Fed Conditions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Actavis Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
研究概览
简要总结
The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30 mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed conditions.
The secondary objective of this study was to evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Test product A (1 x 30 mg KADIAN)
干预措施: KADIAN (morphine sulfate sustained-release) capsules (Drug)
2
Reference product B (1 x 30 mg Avinza)
干预措施: Avinza (morphine sulfate sustained-release) capsules (Drug)
结局指标
主要结局
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
时间窗: 60 hours post-dose
次要结局
- To evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations(monitored throughout study, until resolution)