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

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NCT01286454

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
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
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
  • Drug: fesoterodine
    single dose of beads in capsule
  • Drug: fesoterodine
    single dose of tablet
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01286454
A0221068
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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