A Pilot, Phase I, 2-Period, Fasting, Bioavailability, Safety and PK Study Evaluating A Single Dose Intravenous Fentanyl 200 µg) and Single Doses of 2 or 3 mL AeroLEF (Liposome-Encapsulated Fentanyl 500 µg/mL) in Normal Healthy Non Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.
详细描述
In Period I, subjects received an intravenous dose of fentanyl (200 µg) administered over 1 minute (Treatment A). Subjects then crossed over to Period II.
In Period II, subjects were randomly assigned to receive either 2 mL (1000 µg fentanyl; Treatment B) or 3mL (1500 µg fentanyl; Treatment C) of AeroLEF delivered by nebulization with the AeroEclipse BAN. Subjects were instructed to continue inhalation of AeroLEF for approximately 1 minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered. There was at least a 1 week washout period between study periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking male or female with a minimum age of at least 18 years
- •Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg.
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form.
- •Normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmHg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ECG.
- •Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.
- •If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- •No clinical laboratory values outside of the Principal Investigator's acceptable range, unless the Principal Investigator decided that the subject's values are not clinically significant.
- •Female subjects: (a) if pre-menopausal, have regular menstrual cycles (28-32 days), and (b) are not pregnant prior to study start and avoids pregnancy during the study and 1 month post drug administration, or (c) were surgically sterile for at least 6 months prior to enrollment, or (d) are post-menopausal for at least 1 year prior to enrollment.
排除标准
- •Known history of hypersensitivity to fentanyl.
- •Presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs.
- •History of drug abuse or narcotic dependency.
- •Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives).
- •Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
- •Blood donation within 45 days preceding this trial.
研究组 & 干预措施
A, B, C
干预措施: i.v. fentanyl and AeroLEF (Drug)
结局指标
主要结局
Adverse Events
时间窗: continuously
次要结局
- pharmacokinetics(various time points)