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

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NCT00807118

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00807118
Pfizer
Completed
Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

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Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect
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.
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Therapeutic Equivalency
  • Food
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese healthy male subject

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00807118
A0221052
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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