Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
研究概览
简要总结
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
- •Body mass index (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.
- •Agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
- •Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, tea, coffee, 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 for more information
研究组 & 干预措施
Naloxone
Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
干预措施: Naloxone (Drug)
Naltrexol
Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
干预措施: Naltrexol (Drug)
Naltrexone
Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered
干预措施: Naltrexone (Drug)
结局指标
主要结局
Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]
时间窗: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity \[AUCO-inf\] of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [maximum serum concentration - Cmax]
时间窗: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration \[Cmax\], of naltrexone and naloxone when administered and in combination.
Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]
时间窗: 12 days
The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve \[AUCO-t\] of naltrexone and naloxone when administered and in combination.
次要结局
- Adverse Events(15 days)
- Vital Sign - Blood pressure (systolic)(12 days)
- Vital Sign - Heart Rate(12 days)
- Vital Sign - Respiration Rate(12 days)
- Vital Sign - Blood pressure (diastolic)(12 days)
- Electrocardiogram(12 days)