Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions

An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailability Under Fasting Conditions In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02059915

Enrollment

134

Registered

2014-02-11

Start date

2014-04-30

Completion date

2014-07-31

Last updated

2016-04-04

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

Conditions

Healthy

Keywords

pharmacokinetics, bioequivalence, bioavailability, oxycodone

Brief summary

To Compare The Bioavailability Of 40 Mg Doses Of Pf-00345439 Modified Formulation K Vs. Original Formulation X Under Fed And Fasting Conditions In Healthy Volunteers

Interventions

DRUGOxycodone

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

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	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	—

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	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Concentration at time 24 hours (C24)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—
Plasma Decay Half-Life (t1/2)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—

Countries

United States

Outcome results

None listed

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