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

Pfizer

Status: Completed

Conditions: Healthy

Treatments: Drug: Oxycodone controlled-release test formulation; Drug: Immediate-release reference drug

Study type: Observational

Funder types: Industry

Identifiers

NCT01677065

ALO-02 Bioavailability Study

B4531007

Details and patient eligibility

About

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

Full description

Serial sampling of venous blood

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 2 patient groups

Treatment A

Description:

Controlled release oxycodone test formulation 40 mg

Treatment:

Drug: Oxycodone controlled-release test formulation

Treatment B

Description:

Immediate release oxycodone reference drug 20 mg

Treatment:

Drug: Immediate-release reference drug