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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807118
First Posted: December 11, 2008
Last Update Posted: March 24, 2010
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.
Information provided by:
Pfizer
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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 ]
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00807118     History of Changes
Other Study ID Numbers: A0221052
First Submitted: December 10, 2008
First Posted: December 11, 2008
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Pfizer:
bioequivalence, food effect

Additional relevant MeSH terms:
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents