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ABOUT THIS STUDY
A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two
Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial
Extended Release Capsules
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
Overactive Urinary Bladder
Sex
Females and Males
Age
21-55 years
Inclusion Criteria
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- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive
Exclusion Criteria
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- Evidence or history of clinically significant diseases
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- Helsinki,
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- OYS,
- Tampere,
- Turku,
- Berlin,
- Berlin,
- Frankfurt,
- Hannover,
- Leipzig,
- Muenchen,
- Haifa,
- Haifa,
- Jerusalem,
- Foggia,
- Terracina, LT,
- Hamar,
- Oslo,
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- Trondheim,
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- Porto,
- Porto,
- Porto,
- Bratislava,
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- Kosice - Saca,
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- Martorell, Barcelona
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- Manacor, Palma de Mallorca
- Valencia,
- Eslov,
- Goteborg,
- Malmo,
- Malmo,
- Norrkoping,
- Stockholm,
- Frauenfeld,
- Ankara,
- Istanbul,
- Izmir,
- Samsun,
- Bexhill on Sea, East Sussex
- Leytonstone, London
- Harrow, Middlesex
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- Birmingham,
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- Birmingham, Alabama
- Birmingham, Alabama
- Huntsville, Alabama
- Montgomery, Alabama
- Phoenix, Arizona
- Sun Lakes, Arizona
- Bentonville, Arkansas
- Jonesboro, Arkansas
- Little Rock, Arkansas
- Buena Park, California
- Foothill Ranch, California
- Fresno, California
- West Covina, California
- Colorado Springs, Colorado
- Lakewood, Colorado
- Chipley, Florida
- Davie, Florida
- Hallandale, Florida
- Miami Beach, Florida
- Miami, Florida
- Murdock, Florida
- Ocala, Florida
- Pembroke Pines, Florida
- St. Cloud, Florida
- Tampa, Florida
- Atlanta, Georgia
- Barnesville, Georgia
- Blue Ridge, Georgia
- Decatur, Georgia
- Chicago, Illinois
- Naperville, Illinois
- Orland Park, Illinois
- Newton, Kansas
- Shawnee, Kansas
- Wichita, Kansas
- Wichita, Kansas
- Marrero, Louisiana
- Laurel, Maryland
- Oxon Hill, Maryland
- Jackson, Michigan
- Portage, Michigan
- St. Louis, Missouri
- Las Vegas, Nevada
- Las Vegas, Nevada
- Blackwood, New Jersey
- Mt. Laurel, New Jersey
- Binghamton, New York
- Endicott, New York
- Endwell, New York
- Kingston, New York
- Beaufort, North Carolina
- Charlotte, North Carolina
- Charlotte, North Carolina
- Durham, North Carolina
- Morehead City, North Carolina
- Winston-Salem, North Carolina
- Columbus, Ohio
- Kettering, Ohio
- Central Point, Oregon
- Medford, Oregon
- Bala Cynwyd, Pennsylvania
- Bensalem, Pennsylvania
- Connellsville, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Sellersville, Pennsylvania
- Stoneboro, Pennsylvania
- Warwick, Rhode Island
- Greer, South Carolina
- Simpsonville, South Carolina
- Cordova, Tennessee
- Huntingdon, Tennessee
- Lexington, Tennessee
- Savannah, Tennessee
- Selmer, Tennessee
- Waynesboro, Tennessee
- Austin, Texas
- Bryan, Texas
- Colleyville, Texas
- Friendswood, Texas
- Houston, Texas
- Plano, Texas
- Plano, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- West Jordan, Utah
- West Valley City, Utah
- Spokane, Washington
- Spokane, Washington
- Milwaukee, Wisconsin
- New Berlin, Wisconsin
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Pharmacokinetics and Relative Bioavailability Study | |||
Official Title ICMJE | A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules | |||
Brief Summary | A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules | |||
Detailed Description | Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Other | |||
Condition ICMJE | Urinary Bladder, Overactive | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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 | 16 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 21 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 | Singapore | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01521767 | |||
Other Study ID Numbers ICMJE | A6121196 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |