A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC0-2.5)
研究概览
简要总结
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
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
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range [18.0-30.0] kg/m2 (inclusive).
- •Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions.
排除标准
- •Females who are pregnant or lactating.
- •Current or recent (within 5 years) history of drug or alcohol abuse.
- •History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- •Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride.
- •Dosing in a clinical drug study during the 30 days preceding the initial dose in this study.
- •Any significant illness during the 30 days preceding the initial dose in this study
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Treatment A
Nalmefene + 0.94% MgCl2 (IV)
干预措施: Nalmefene + 0.94% MgCl2 (Drug)
Treatment B
Nalmefene + 0.94% MgCl2 (IM)
干预措施: Nalmefene + 0.94% MgCl2 (Drug)
Treatment C
Nalmefene Hydrochloride injection
干预措施: Nalmefene Hydrochloride Injection (Drug)
结局指标
主要结局
Area Under the Curve (AUC0-2.5)
时间窗: 2.5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-5)
时间窗: 5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-10)
时间窗: 10 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-15)
时间窗: 15 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-20)
时间窗: 20 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-30)
时间窗: 30 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUCt)
时间窗: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUCinf)
时间窗: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Maximum Plasma Concentration (Cmax)
时间窗: Up to 48 hours post-dose
Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
次要结局
未报告次要终点