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

Last updated on November 15, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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.
Show details

- 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.
Show details

- Evidence or history of clinically significant disease

NCT01286454
Pfizer
Completed
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

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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 SummaryThis Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Detailed DescriptionTo 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 DateMarch 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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