A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).
详细描述
Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •18-60 50 years of age
- •Provide written informed consent prior to completing any study specific procedure.
- •Body Mass Index (BMI) range 18.5-30 kg/m2
- •Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
- •Using reliable contraception
排除标准
- •Intranasal problems
- •Taking prescribed or over the counter medications
- •Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.
研究组 & 干预措施
Test Product Dose 1
干预措施: MVP005 (Drug)
Test Product Dose 2
干预措施: MVP005 (Drug)
Comparator Product
干预措施: Naloxone hydrochloride solution for injection with mucosal atomization device (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm
Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2)
次要结局
- Number of subjects with adverse events(14 days)
- Physical Examination(14 days)
- Vital signs(14 days)
- ECGs(14 days)
- Safety Laboratory Tests(14 days)