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Completed

NCT Number: NCT01717027

Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

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

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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

New Haven, Connecticut, 06511, United States

About this study

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.

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 (inclusive).

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 A, single dose, taken whole and under fed conditions

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

  3. Plasma Decay Half-Life of oxycodone, as data permit.

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

  4. Concentration at time 24 hours (C24) of oxycodone, as data permit.

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Pain Therapeutics

Industry

Registry information

Official study title

Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Conditions In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Aug 31, 2015

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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