A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01552863

Enrollment

Registered

2012-03-13

Start date

2012-03-31

Completion date

2012-09-30

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

Pain

Keywords

pharmacokinetics, bioavailability, oxycodone.

Brief summary

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Detailed description

This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Interventions

DRUGOxycodone

One capsule of 40 mg PF-00345439 Formulation A, single dose

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. * History of obstructive sleep apnea. * Positive urine drug test.

Design outcomes

Primary

Measure	Time frame
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

Secondary

Measure	Time frame
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Plasma Concentration 24 Hours Post-Dose (C24)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose.
Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Plasma Decay Half-Life (t1/2)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E	0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

Countries

United States

Outcome results

None listed

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