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

An Open-label, Single-dose, 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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01677065

Enrollment

Registered

2012-08-31

Start date

2012-09-30

Completion date

2012-10-31

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, Oxycodone, Healthy Volunteers

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

Interventions

DRUGOxycodone controlled-release test formulation

single dose administration of test formulation under fasted conditions

DRUGImmediate-release reference drug

single dose administration of reference drug under fasted conditions

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetic endpoints - area under the concentration curve (AUC)	0-48 hr

Secondary

Measure	Time frame
Peak concentration (Cmax) and time to peak concentration (Tmax)	0-48 hr

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026