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This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

NCT ID: NCT01286454

Last Updated: 2012-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

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Detailed Description

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To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Conditions

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Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

4 mg fesoterodine IR beads in capsule under fasting condition

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of beads in capsule

B

4 mg fesoterodine 10% coated ER beads in capsule under fasting condition

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of beads in capsule

C

4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of beads in capsule

D

4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of beads in capsule

E

4 mg fesoterodine ER tablets under fasting condition.

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of tablet

F

4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.

Group Type EXPERIMENTAL

fesoterodine

Intervention Type DRUG

single dose of beads in capsule

Interventions

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fesoterodine

single dose of beads in capsule

Intervention Type DRUG

fesoterodine

single dose of beads in capsule

Intervention Type DRUG

fesoterodine

single dose of beads in capsule

Intervention Type DRUG

fesoterodine

single dose of beads in capsule

Intervention Type DRUG

fesoterodine

single dose of tablet

Intervention Type DRUG

fesoterodine

single dose of beads in capsule

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

Exclusion Criteria

* Evidence or history of clinically significant disease
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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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=A0221068&StudyName=This%20Is%20A%20Study%20Of%20Bioavailability%20And%20Food%20Effect%20For%20Fesoterodine.

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

Other Identifiers

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A0221068

Identifier Type: -

Identifier Source: org_study_id

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