Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01924676

Enrollment

Registered

2013-08-16

Start date

2013-08-31

Completion date

2013-10-31

Last updated

2015-08-31

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

Conditions

Healthy

Keywords

food effect, pharmacokinetics, bioavailability, oxycodone, management of moderate to severe pain

Brief summary

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

Detailed 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.

Interventions

DRUGOxycodone

One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	—

Secondary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Concentration at time 24 hours (C24) of oxycodone, as data permit.	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	Concentration at time 24 hours (C24) of oxycodone, as data permit.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

United States

Outcome results

None listed

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