Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

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NCT00807118

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Study Location
Pfizer Investigational Site
Shinjuku-ku, Tokyo, , Japan
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Therapeutic Equivalency, Food
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese healthy male subject

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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
  1. Shinjuku-ku, Tokyo
Male
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Therapeutic Equivalency
  • Food
Intervention  ICMJE
  • Drug: Fesoterodine
    Single dose of 2 x 4 mg tab in formulation F under fed condition
  • Drug: Fesoterodine
    Single dose of 1 x 8 mg tab in formulation F under fed condition
  • Drug: Fesoterodine
    Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
  • Drug: Fesoterodine
    Single dose of 2 x 4 mg tab in formulation F under fasted condition
  • Drug: Fesoterodine
    Single dose of 1 x 8 mg tab in formulation F under fasted condition
Study Arms  ICMJE
  • Experimental: A (Cohort I)
    Intervention: Drug: Fesoterodine
  • Experimental: B (Cohort I)
    Intervention: Drug: Fesoterodine
  • Experimental: C (Cohort I)
    Intervention: Drug: Fesoterodine
  • Experimental: B (Cohort II)
    Intervention: Drug: Fesoterodine
  • Experimental: D (Cohort II)
    Intervention: Drug: Fesoterodine
  • Experimental: E (Cohort II)
    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
Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)		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:

  • Japanese healthy male subject

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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
Study Director:Pfizer CT.gov Call CenterPfizer
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