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OpenTrials
Completed

NCT Number: NCT02059915

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Saint Paul, Minnesota, 55114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

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

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 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).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 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)

  2. Concentration at time 24 hours (C24)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

  4. Plasma Decay Half-Life (t1/2)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48

Sponsors and collaborators

Lead sponsor

Pain Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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