Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of naloxone
研究概览
简要总结
Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
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
- •Males and females 18 to 55 years of age, inclusive
- •Provide written informed consent
- •BMI ranging from 18 to 32 kg/m2, inclusive
- •Adequate venous access
- •No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG
- •Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
- •Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
- •Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study
排除标准
- •Contact site directly for more information
研究组 & 干预措施
Mucosal Atomization (1 administration)
One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)
干预措施: Mucosal atomization device and syringe (Device)
Mucosal Atomization (1 administration)
One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)
干预措施: Naloxone (Drug)
Mucosal Atomization (2 administrations)
Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart
干预措施: Naloxone (Drug)
Mucosal Atomization (2 administrations)
Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart
干预措施: Mucosal atomization device and syringe (Device)
Narcan 2mg
One Intranasal administration of 2 mg naloxone using Narcan nasal spray
干预措施: Naloxone (Drug)
Narcan 2mg
One Intranasal administration of 2 mg naloxone using Narcan nasal spray
干预措施: Narcan (Device)
Narcan 4mg
One Intranasal administration of 4 mg naloxone using Narcan nasal spray
干预措施: Naloxone (Drug)
Narcan 4mg
One Intranasal administration of 4 mg naloxone using Narcan nasal spray
干预措施: Narcan (Device)
Intramuscular auto injector
One Intramuscular administration of 2 mg naloxone using Evzio auto-injector
干预措施: Naloxone (Drug)
Intramuscular auto injector
One Intramuscular administration of 2 mg naloxone using Evzio auto-injector
干预措施: Intramuscular Auto Injector (Device)
结局指标
主要结局
Pharmacokinetic parameters of naloxone
时间窗: 11 days
Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve
次要结局
- Safety Assessments(16 days)