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A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

NCT ID: NCT01552863

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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pharmacokinetics bioavailability oxycodone.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Treatment B

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Treatment C

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Treatment D

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Treatment E

Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

One capsule of 5 mg PF-00345439 Formulation TBD, single dose

Treatment F

Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Interventions

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Oxycodone

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Oxycodone

One capsule of 5 mg PF-00345439 Formulation TBD, single dose

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pain Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4501018&StudyName=A%20Study%20To%20Characterize%20The%20Pharmacokinetics%20Of%20Oxycodone%20In%20Healthy%20Volunteers

To obtain contact information for a study center near you, click here.

Other Identifiers

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B4501018

Identifier Type: -

Identifier Source: org_study_id