A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Completed

• Conditions: Healthy
• Interventions: Drug: Oxycodone controlled-release test formulation; Drug: Immediate-release reference drug

• Registration Number: NCT01677065
• Lead Sponsor: Pfizer

Brief Summary

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Detailed Description

Serial sampling of venous blood

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-08-31
• Study Start: 2012-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion Criteria

• Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment A	Oxycodone controlled-release test formulation	Controlled release oxycodone test formulation 40 mg
Treatment B	Immediate-release reference drug	Immediate release oxycodone reference drug 20 mg

Primary Outcome Measures

Name	Time	Method
pharmacokinetic endpoints - area under the concentration curve (AUC)	0-48 hr

Secondary Outcome Measures

Name	Time	Method
Peak concentration (Cmax) and time to peak concentration (Tmax)	0-48 hr

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States