NCT00801788已完成1 期
Single Dose Pharmacokinetics of Egalet® Oxycodone
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 16
- 主要终点
- To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Egalet® oxycodone Treatment A
Experimental
Single Dose Administration
干预措施: Oxycodone hydrochloride (Drug)
Egalet® oxycodone Treatment B
Experimental
Single Dose Administration
干预措施: Oxycodone hydrochloride (Drug)
Egalet® oxycodone Treatment C
Experimental
Single Dose Administration
干预措施: Oxycodone hydrochloride (Drug)
Active comparator
Active Comparator
Single Dose Administration
干预措施: Oxycodone hydrochloride (Drug)
结局指标
主要结局
To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.
时间窗: Single-dose evaluation
次要结局
- To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.(Single-dose evaluation)
研究者
相似试验
已完成
1 期
Single Dose Pharmacokinetics of Egalet® HydrocodonePainNCT00802087Egalet Ltd28
已完成
1 期
Pharmacokinetics Study of ALO-02 and OxyContinManagement of Moderate to Severe PainNCT01557257Pfizer13
招募中
1 期
Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)PharmacokineticsNCT06500793Ensysce Biosciences54
已完成
1 期
Pharmacokinetics of Oxycodone and PF614 Co-Administered With NafamostatPharmacokineticsNCT05090280Ensysce Biosciences111
已完成
1 期
Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy SubjectsHealthyNCT04144192Scilex Pharmaceuticals, Inc.58