A Single-dose Crossover Study of Fentanyl Sublingual Spray 400 Mcg Versus Actiq® 400 Mcg Versus Fentanyl Citrate Injection (iv) 100 Mcg Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to reach the maximum drug concentration (Tmax) in plasma
研究概览
简要总结
The objective of this study was to compare the rate of absorption and bioavailability of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously.
详细描述
This was a Phase I, single-dose, open-label, randomized, 3-period, 3-treatment cross over study in which 21 healthy subjects received single doses of fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously following a 10-hour overnight fast. There was a 7 day washout period between treatments.
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
- •Male or non-pregnant, non-breast-feeding female between the ages of 18-55 inclusive.
- •Body Mass Index (BMI) between 18-30 kg/m^2, inclusive, and body weight of at least 60 kg (132 lbs).
- •Subject was healthy according to the medical history, laboratory results, and physical examination.
排除标准
- •Had a presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
- •Had a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
- •Had a significant history of hypersensitivity to opioid analgesics, fentanyl or any related products, naltrexone, or severe hypersensitivity reactions (like angioedema) to any drugs.
- •Had a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- •Had donated blood or plasma within 30 days prior to the first dose of study medication or during the course of this study.
- •Had participated in another clinical trial within 30 days prior to the first dose of study medication or during the course of this study.
- •Had used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication or during the course of this study.
- •Had used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication or during the course of this study.
- •Had used enzyme altering drugs such as barbiturates, corticosteroids, phenothiazines, cimetidine, carbamazepine, etc, within 30 days prior to the first dose of study medication or during the course of this study.
- •Had used opioid analgesics within the last 30 days.
研究组 & 干预措施
Fentanyl 400 µg sublingual spray + naltrexone 50 mg
Patients received a single administration of 400 µg of fentanyl spray sublingually + naltrexone hydrochloride 50 mg orally.
干预措施: Fentanyl 400 µg sublingual spray (Drug)
Fentanyl 400 µg sublingual spray + naltrexone 50 mg
Patients received a single administration of 400 µg of fentanyl spray sublingually + naltrexone hydrochloride 50 mg orally.
干预措施: Naltrexone 50 mg (Drug)
Actiq® 400 µg transmucosally + naltrexone 50 mg
Patients received a single administration of 400 µg of Actiq® transmucosally + naltrexone hydrochloride 50 mg orally.
干预措施: Actiq® 400 µg transmucosally (Drug)
Actiq® 400 µg transmucosally + naltrexone 50 mg
Patients received a single administration of 400 µg of Actiq® transmucosally + naltrexone hydrochloride 50 mg orally.
干预措施: Naltrexone 50 mg (Drug)
Fentanyl citrate injection 100 µg iv + naltrexone 50 mg
Patients received a single administration of 100 µg of fentanyl citrate intravenously + naltrexone hydrochloride 50 mg orally.
干预措施: Fentanyl citrate injection 100 µg intravenously (Drug)
Fentanyl citrate injection 100 µg iv + naltrexone 50 mg
Patients received a single administration of 100 µg of fentanyl citrate intravenously + naltrexone hydrochloride 50 mg orally.
干预措施: Naltrexone 50 mg (Drug)
结局指标
主要结局
Time to reach the maximum drug concentration (Tmax) in plasma
时间窗: Up to 60 minutes pre-dose to 36 hours post-dose
次要结局
- Maximum drug concentration (Cmax) in plasma(Up to 60 minutes pre-dose to 36 hours post-dose)
- Area under the plasma concentration-time curve from time-0 to the time of the last quantifiable concentration (AUClast)(Up to 60 minutes pre-dose to 36 hours post-dose)
- Area under the plasma concentration-time curve from time-0 extrapolated to infinity (AUCinf)(Up to 60 minutes pre-dose to 36 hours post-dose)
- Percentage of AUCinf based on extrapolation (AUCextrap)(Up to 60 minutes pre-dose to 36 hours post-dose)
- Observed elimination rate constant (λz)(Up to 60 minutes pre-dose to 36 hours post-dose)
- Observed terminal elimination half-life (T1/2)(Up to 60 minutes pre-dose to 36 hours post-dose)
- Time of the last measurable concentration of drug (Tlast) in plasma(Up to 60 minutes pre-dose to 36 hours post-dose)
- Last quantifiable drug concentration (Clast) in plasma(Up to 60 minutes pre-dose to 36 hours post-dose)