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

November 5, 2008
September 8, 2010
January 2009
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00786240 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase1, Single Dose, Crossover Study to Determine Bioequivalence
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.

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Fesoterodine
    Single dose of 4 mg tablet in formulation D under fasted conditions (Reference)
  • Drug: Fesoterodine
    Single dose of 4 mg tablet in formulation E(1) under fasted conditions (Test)
  • Experimental: A
    Intervention: Drug: Fesoterodine
  • Experimental: B
    Intervention: Drug: Fesoterodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female Chinese or Japanese subjects

Exclusion Criteria:

  • Evidence or history of clinically significant findings at screening
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00786240
A0221063
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP