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

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NCT01286454

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urgency Overactive Bladder (OAB) With Symptoms of Frequency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant disease

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Urgency Overactive Bladder (OAB) With Symptoms of FrequencyThis Is A Study Of Bioavailability And Food Effect For Fesoterodine.
NCT01286454
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Official Title  ICMJE An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers
Brief Summary This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
Intervention  ICMJE
  • Drug: fesoterodine
    single dose of beads in capsule
  • Drug: fesoterodine
    single dose of tablet
Study Arms  ICMJE
  • Experimental: A
    4 mg fesoterodine IR beads in capsule under fasting condition
    Intervention: Drug: fesoterodine
  • Experimental: B
    4 mg fesoterodine 10% coated ER beads in capsule under fasting condition
    Intervention: Drug: fesoterodine
  • Experimental: C
    4 mg fesoterodine 15% coated ER beads in capsule under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: D
    4 mg fesoterodine 20% coated ER beads in capsule under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: E
    4 mg fesoterodine ER tablets under fasting condition.
    Intervention: Drug: fesoterodine
  • Experimental: F
    4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.
    Intervention: Drug: fesoterodine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2011)		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01286454
Other Study ID Numbers  ICMJE A0221068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP