Pharmacokinetics 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

NCT01717027

B4501034

Details and patient eligibility

About

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Full description

This study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulations J and K compared with the reference PF-00345439 Formulation A, all taken whole and under fed conditions in healthy volunteers.

In addition, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that taken whole in the fed state in healthy volunteers, and assess the single-dose safety and tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Enrollment: 19 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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19 participants in 4 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

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

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

Drug: Oxycodone

Treatment D

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

Drug: Oxycodone