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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00807118
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Last Update Posted Date March 24, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition [ Time Frame: Day 1 and 2 ]
  • AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition [ Time Frame: Day 1 and 2 ]
  • AUCt and Cmax of 5-HMT under after single oral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1) [ Time Frame: Day 1 and 2 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
  • AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablets of formulation F under fed condition [ Time Frame: Day 1 and 2 ]
  • AUCt and Cmax of 5-HMT under after singleoral administration of 1 tab of 8 mg fesoterodine SR tablets of formulation F and 1 tab of 8 mg fesoterodine SR tablet of formulation E(1) [ Time Frame: Day 1 and 2 ]
  • AUCt and Cmax of 5-HMT after single oral administration of 2 tabs of 4 mg fesoterodine SR tablets of formulation Fand 1 tab of 8 mg fesoterodine SR tablets of formulation F under fasted condition [ Time Frame: Day 1 and 2 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
  • Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment [ Time Frame: Day 1 and 2 ]
  • AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II [ Time Frame: Day 1 and 2 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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