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Pharmacokinetics And Relative Bioavailability Study Of Oxycodone

NCT ID: NCT01552850

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

2012-04-30

Study Completion Date

2012-06-30

Brief Summary

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To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution

Detailed Description

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This study will estimate the PK and relative bioavailability of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the reference Formulation A under fed conditions.

Conditions

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Pain

Keywords

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pharmacokinetics relative 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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Oxycodone Formulation A Capsule

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

1X40 mg PF-00345439 formulation A capsule with water and under fed condition

Oxycodone Formulation B Capsule

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

1X40 mg PF-00345439 formulation B capsule with water and under fed condition

Oxycodone Formulation C Capsule

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

1X40 mg PF-00345439 formulation C capsule with water and under fed condition

Oxycodone Formulation D Capsule

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

1X40 mg PF-00345439 formulation D capsule with water and under fed condition

Oxycodone Oral Solution

40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

Interventions

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Oxycodone

1X40 mg PF-00345439 formulation A capsule with water and under fed condition

Intervention Type DRUG

Oxycodone

1X40 mg PF-00345439 formulation B capsule with water and under fed condition

Intervention Type DRUG

Oxycodone

1X40 mg PF-00345439 formulation C capsule with water and under fed condition

Intervention Type DRUG

Oxycodone

1X40 mg PF-00345439 formulation D capsule with water and under fed condition

Intervention Type DRUG

Oxycodone

40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion Criteria

* Evidence or history of clinically significant diseases
Minimum Eligible Age

21 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

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4501010&StudyName=Pharmacokinetics%20And%20Relative%20Bioavailability%20Study%20Of%20Oxycodone%0A

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

Other Identifiers

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B4501010

Identifier Type: -

Identifier Source: org_study_id