NCT00802087已完成1 期
A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.
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
- 28
- 主要终点
- To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.
详细描述
Outcomes:
Pharmacokinetic parameters and bioequivalence testing.
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
- •Non-smokers
- •≥18 and ≤55 years of age
- •BMI ≥19 and ≤30.0
排除标准
- •Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
- •History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
- •Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
- •Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
- •Pregnant or breast-feeding
研究组 & 干预措施
Egalet® hydrocodone Treatment B
Experimental
Single Dose Administration
干预措施: hydrocodone (Drug)
Egalet® hydrocodone Treatment C
Experimental
Single Dose Administration
干预措施: hydrocodone (Drug)
Egalet® hydrocodone treatment A
Experimental
Single Dose administration
干预措施: hydrocodone (Drug)
Egalet® hydrocodone Treatment D
Experimental
Single Dose Administration
干预措施: hydrocodone (Drug)
Active Comparator
Active Comparator
Single Dose Administration
干预措施: hydrocodone & acetaminophen combination (Drug)
结局指标
主要结局
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
时间窗: Single-dose evaluation
次要结局
- To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.(Single-dose evaluation)
研究者
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