A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

NCT ID: NCT01366287

Last Updated: 2011-06-06

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-02-28

Brief Summary

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The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

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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Suspension/fasted

Group Type EXPERIMENTAL

PF-03882845

Intervention Type DRUG

25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition

Tablet/fasted

Group Type EXPERIMENTAL

PF-03882845

Intervention Type DRUG

25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition

Tablet/fed

Group Type EXPERIMENTAL

PF-03882845

Intervention Type DRUG

25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

Interventions

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PF-03882845

25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition

Intervention Type DRUG

PF-03882845

25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition

Intervention Type DRUG

PF-03882845

25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

* Serum potassium \>5 mEq/L at screening.
* Impaired kidney function (estimated GFR \<60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

Other Identifiers

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B0171006

Identifier Type: -

Identifier Source: org_study_id

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