Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasma Concentration (AUC 0-inf)
研究概览
简要总结
To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.
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 30 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 throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 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.
- •Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.
排除标准
- •Please contact site for more information
研究组 & 干预措施
50mg Naltrexone
Administer 50mg formulation orally
干预措施: Naltrexone (Drug)
4mg Intranasal Naltrexone
Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
干预措施: Naltrexone (Drug)
4mg Intranasal Naltrexone with Intravail
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
干预措施: Naltrexone (Drug)
4mg Intranasal Naltrexone with Intravail
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
干预措施: Intravail (Other)
2mg Intramuscular Naltrexone
Administer 2 mg formulation intramuscularly
干预措施: Naltrexone (Drug)
结局指标
主要结局
Plasma Concentration (AUC 0-inf)
时间窗: 48 hours
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Plasma Concentration (Cmax)
时间窗: 48 hours
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Plasma Concentration (Tmax)
时间窗: 48 hours
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
Plasma Concentration (AUC 0-t)
时间窗: 48 hours
Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration
次要结局
- Vital Signs(12 days)
- 12-lead electrocardiogram(12 days)
- Nasal Irritation Scoring(5 days)
- Adverse Events(Maximum of 18 days)