An Open-label, Single-dose and Multiple-dose, Randomized, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability After Administration of ALO-02 40 Mg Twice Daily Compared to ALO-02 80 Mg Once Daily and to Oxycontin 40 Mg Twice Daily in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone
研究概览
简要总结
To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily 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
- Basic Science
- 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
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
排除标准
- •Evidence or history of clinically significant diseases.
研究组 & 干预措施
40 mg ALO-02 capsule
Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block
干预措施: ALO-02 (Drug)
40 mg ALO-02 capsule
Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block
干预措施: Naltrexone block (Drug)
80 mg ALO-02 capsule
Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block
干预措施: ALO-02 (Drug)
80 mg ALO-02 capsule
Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block
干预措施: Naltrexone block (Drug)
40 mg OxyContin tablet
Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
干预措施: OxyContin (Drug)
40 mg OxyContin tablet
Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
干预措施: Naltrexone block (Drug)
结局指标
主要结局
Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone
时间窗: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing
Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone
时间窗: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing
Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone
时间窗: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing
Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Area under the plasma concentration versus time curve within a dosing interval of τ at steady state (AUCτ) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Maximum plasma concentration at steady state on Day 5 (Cmax,ss) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Minimum plasma concentration at steady state on Day 5 (Cmin,ss) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Average plasma concentration at steady state on Day 5 (Cave,ss) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration on Day 5 (Tmax) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Plasma Decay Half-Life (t1/2) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
Multiple-dose administration: Accumulation ratio based on Area Under Curve (AUC) (Rac) of oxycodone, as data permit.
时间窗: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing
次要结局
- Multiple-dose administration: Rac of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Single-dose administration: Dose normalized Maximum Observed Plasma Concentration (Cmax(dn)) of oxycodone, noroxycodone, and oxymorphone.(0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing)
- Single-dose administration: Dose-normalized Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24(dn)) of oxycodone, noroxycodone, and oxymorphone.(0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing)
- Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone.(0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing)
- Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone.(0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing)
- Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone.(0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing)
- Multiple-dose administration: Accumulation ratio (Rac) of oxycodone, as data permit(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone, as data permit(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Area under the plasma concentration versus time curve within a dosing interval of τ (AUCτ) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Maximum plasma concentration at steady state (Cmax,ss) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Minimum plasma concentration at steady state (Cmin,ss) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Average plasma concentration at steady state (Cave,ss) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)
- Multiple-dose administration: Plasma Decay Half-Life (t1/2) of noroxycodone and oxymorphone, as data permit.(96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing)