This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
NCT01286454
Last updated date
ABOUT THIS STUDY
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Urgency Overactive Bladder (OAB) With Symptoms of Frequency
Sex
Females and Males
Age
18-55 years
Inclusion Criteria
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- Healthy male and/or female subjects between the ages of 18 and 55 years
Exclusion Criteria
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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
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |