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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

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

ClinicalTrials.gov processed this record on November 25, 2014