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Phase1, Single Dose, Crossover Study to Determine Bioequivalence

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00786240
First received: November 5, 2008
Last updated: September 8, 2010
Last verified: September 2010
History of Changes
  Purpose

The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).


Condition Intervention Phase
Healthy
 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-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) 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 4 mg fesoterodine SR tablets in formulation D under fasted conditions [ Time Frame: Day 1 and 2 ] [ Designated as safety issue: No ]
  • AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions [ Time Frame: Day 1 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions [ Time Frame: Day 1 and 2 ] [ Designated as safety issue: No ]
  • Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions [ Time Frame: Day 1 and 2 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Fesoterodine
Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
Experimental: B Drug: Fesoterodine
Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female Chinese or Japanese subjects

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786240

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
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: NCT00786240     History of Changes
Other Study ID Numbers: A0221063
Study First Received: November 5, 2008
Last Updated: September 8, 2010
Health Authority: Singapore: Health Science Authority

Keywords provided by Pfizer:
Bioequivalence
Therapeutic Equivalency

ClinicalTrials.gov processed this record on May 16, 2013