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This study is ongoing, but not recruiting participants.
First Received on October 13, 2011. Last Updated on December 14, 2011 History of ChangesSponsor:PfizerInformation provided by (Responsible Party):PfizerClinicalTrials.gov Identifier:NCT01456507 PurposeThe purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Condition
Drug: ALO-02 (Oxycodone Naltrexone)
Healthy
Intervention
Phase
Phase I
Study Type:InterventionalStudy Design:Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open LabelOfficial Title:An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
Resource links provided by NLM:
Drug Information available for: Naltrexone Naltrexone hydrochloride Oxycodone Oxycodone hydrochlorideU.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:Area Under the Curve (AUC) to time infinity (inf) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
Maximum Plasma Concentration (Cmax) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ] [ Designated as safety issue: No ]
AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit [ Time Frame: predose, 1,2,4,8,12,24,48,120 hours post-dose ] [ Designated as safety issue: No ]
Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. [ Time Frame: over 120 hours ] [ Designated as safety issue: Yes ]
Estimated Enrollment:24
Study Start Date:October 2011
Estimated Study Completion Date:December 2011
Estimated Primary Completion Date:December 2011 (Final data collection date for primary outcome measure)
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