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Phase1, Single Dose, Crossover Study to Determine Bioequivalence

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ClinicalTrials.gov Identifier: NCT00786240
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Fesoterodine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : January 2009
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00786240


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00786240     History of Changes
Other Study ID Numbers: A0221063
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010

Keywords provided by Pfizer:
Bioequivalence
Therapeutic Equivalency

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