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临床试验/NCT01595867
NCT01595867已完成1 期

A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration

Pfizer0 个研究点目标入组 33 人开始时间: 2010年8月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Pfizer
入组人数
33
主要终点
Drug Liking Visual Analog Scale maximum peak effect (Emax)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

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

  • •Healthy male or female subjects 18 to 55 years of age, inclusive.
  • •Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
  • •Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.

排除标准

  • •Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
  • •Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
  • •Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
  • •Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
  • •History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
  • •History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.

研究组 & 干预措施

Treatment A

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

Treatment B

Experimental

EMBEDA 30 mg crushed

干预措施: EMBEDA - morphine sulfate/ naltrexone hydrochloride (Drug)

Treatment C

Active Comparator

Morphine Sulfate Controlled Release 30 mg crushed

干预措施: morphine sulfate CR crushed. (Drug)

结局指标

主要结局

Drug Liking Visual Analog Scale maximum peak effect (Emax)

时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose

Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)

时间窗: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose

High Visual Analog Scale maximum peak effect (Emax)

时间窗: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose

High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)

时间窗: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose

次要结局

  • High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • High Visual Analog Scale Area time to maximum effect (TEmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale maximum peak effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale maximum peak effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale maximum peak effect (Emax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale maximum peak effect (Emax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Nausea Visual Analog Scale Area time to maximum effect (TEmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale maximum peak effect (Emax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Sleepy Visual Analog Scale Area time to maximum effect (TEmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale maximum peak effect (Emax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Dizzy Visual Analog Scale Area time to maximum effect (TEmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter minimum peak effect (Emin)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter time to minimum peak effect (TEmin)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose)
  • Take Drug Again Visual Analog Scale maximum peak effect (Emax)(12 and 24 hours post dose)
  • Take Drug Again Visual Analog Scale mean (Emean)(12 and 24 hours post dose)
  • Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)(12 and 24 hours post dose)
  • Overall Drug Liking Visual Analog Scale mean (Emean)(12 and 24 hours post dose)
  • Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Burning maximum peak effect (Emax)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)(pre dose and 0.5, 1, 1.5, and 2 hours post dose)
  • Plasma morphine - Maximum observed plasma concentration (Cmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Time to maximum observed plasma concentration (Tmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Maximum observed plasma concentration (Cmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)
  • Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)(pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

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