Pharmacokinetics Study of ALO-02 and OxyContin
Phase 1
Completed
- Conditions
- Management of Moderate to Severe Pain
- Interventions
- Registration Number
- NCT01557257
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
Exclusion Criteria
- Evidence or history of clinically significant diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 40 mg OxyContin tablet Naltrexone block Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block 80 mg ALO-02 capsule ALO-02 Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block 40 mg ALO-02 capsule ALO-02 Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block 40 mg ALO-02 capsule Naltrexone block Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block 80 mg ALO-02 capsule Naltrexone block Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block 40 mg OxyContin tablet OxyContin Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
- Primary Outcome Measures
Name Time Method Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone 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 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 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
- Secondary Outcome Measures
Name Time Method 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: 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: 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States