A Phase 1 interventional study of ALO-02 and Naltrexone block in Management of Moderate to Severe Pain, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-28.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block
Drug: ALO-02 · Drug: Naltrexone block
Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block
Drug: ALO-02 · Drug: Naltrexone block
Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
Drug: OxyContin · Drug: Naltrexone block
Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily)
Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily)
Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose and 11.5 hours after the AM dosing on Days 2-5, (3) 23.5 hours after Day 5 dosing.
Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily)
Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer