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
  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:


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
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: 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:
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 July 22, 2014