Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
NCT00807118
Last updated date
ABOUT THIS STUDY
Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial
formulation in both under fasted and fed condition, and bioequivalence between formulation
E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective
is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set
to get data for Japanese regulatory submission.
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
Therapeutic Equivalency, Food
Sex
Male
Age
20-55 years
Inclusion Criteria
Show details
- Japanese healthy male subject
Exclusion Criteria
Show details
- Evidence or history of clinically significant findings at screening
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Therapeutic Equivalency, FoodPhase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
NCT00807118
- Shinjuku-ku, Tokyo
Male
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
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Brief Title ICMJE | Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect | |||
Official Title ICMJE | A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 3-Way Crossover Study To Determine Bioequivalence Of 4 Mg And 8 Mg Fesoterodine SR Tablet Of Commercial Formulation And 8 Mg Fesoterodine SR Tablet Between Formulation E(1) And Formulation F And Investigate Food Effect On Commercial Formulation In Healthy Subjects. | |||
Brief Summary | Primary objectives are to demonstrate bioequivalence between 4 and 8 mg of commercial formulation in both under fasted and fed condition, and bioequivalence between formulation E(1) used in Japanese pivotal study and commercial formulation in 8 mg. Secondary objective is to assess food effect on 8 mg tablet of commercial formulation. These objectives are set to get data for Japanese regulatory submission. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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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 | |||
Estimated Enrollment ICMJE | 108 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2008 | |||
Actual Primary Completion Date | December 2008 (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 | 20 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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00807118 | |||
Other Study ID Numbers ICMJE | A0221052 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |