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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00807118
First received: December 10, 2008
Last updated: March 23, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Therapeutic Equivalency
Food
 Drug: Fesoterodine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment [ Time Frame: Day 1 and 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (Cohort I) Drug: Fesoterodine
Single dose of 2 x 4 mg tab in formulation F under fed condition
Experimental: B (Cohort I) Drug: Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fed condition
Experimental: C (Cohort I) Drug: Fesoterodine
Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
Experimental: B (Cohort II) Drug: Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fed condition
Experimental: D (Cohort II) Drug: Fesoterodine
Single dose of 2 x 4 mg tab in formulation F under fasted condition
Experimental: E (Cohort II) Drug: Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fasted condition

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese healthy male subject

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807118

Locations
Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00807118     History of Changes
Other Study ID Numbers: A0221052
Study First Received: December 10, 2008
Last Updated: March 23, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
bioequivalence, food effect

ClinicalTrials.gov processed this record on May 23, 2013