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Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

NCT ID: NCT01924676

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-10-31

Brief Summary

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To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Detailed Description

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This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Conditions

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Healthy

Keywords

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food effect pharmacokinetics bioavailability oxycodone management of moderate to severe pain

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 X, single dose, under fasting conditions

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 K, single dose, under fasting conditions

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 K, single dose, under fed conditions

Interventions

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Oxycodone

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

Intervention Type DRUG

Oxycodone

One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions

Intervention Type DRUG

Oxycodone

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

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
* 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

Baltimore, Maryland, 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=B4501022&StudyName=Food%20Effect%20And%20Relative%20Bioavailability%20Study%20Of%20Oxycodone%20in%20Healthy%20Volunteers

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Other Identifiers

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B4501022

Identifier Type: -

Identifier Source: org_study_id