A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 40-mg Tablets to OxyContin® 40-mg Tablets
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Plasma Concentration
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fasted state.
详细描述
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18 to 50, inclusive.
- •Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
- •Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
- •Females of child-bearing potential must be using an adequate and reliable method of contraception.
排除标准
- •Females who are pregnant or lactating.
- •Any history of or current drug or alcohol abuse for 5 years.
- •History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- •Use of an opioid-containing medication in the past 30 days.
- •History of known sensitivity to oxycodone, naltrexone, or related compounds.
- •Any history of frequent nausea or emesis regardless of etiology.
- •Any history of seizures or head trauma with current sequelae.
- •Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
- •Any significant illness during the 30 days preceding the initial dose in this study.
- •Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
- •Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
- •Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
- •History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
- •Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
- •Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.
- •Positive Naloxone HCl challenge test.
- •Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
研究组 & 干预措施
Reformulated OXY 40 mg
Reformulated OXY 40 mg x 1 dose
干预措施: Reformulated OXY (oxycodone HCl) (Drug)
Original OxyContin® (OXY) 40 mg
Original OxyContin® (OXY) 40 mg x 1 dose
干预措施: Original OxyContin® (OXY) (oxycodone HCl) (Drug)
结局指标
主要结局
Cmax - Maximum Observed Plasma Concentration
时间窗: Blood samples collected over 72-hour period
Bioequivalence based on Cmax
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
时间窗: Blood samples collected over 72-hour period
Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 72-hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点