Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Pain Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxycodone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01924676

B4501022

Details and patient eligibility

About

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Full description

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion criteria

• Evidence or history of clinically significant disease
• Positive urine drug test

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Treatment A

Experimental group

Description:

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment B

Experimental group

Description:

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone

Treatment C

Experimental group

Description:

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Treatment:

Drug: Oxycodone

Drug: Oxycodone

Drug: Oxycodone