Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect

Therapeutic Equivalency Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807118
• Other study ID #: A0221052
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2008
• Last updated: March 23, 2010
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Japanese healthy male subject

Exclusion Criteria:

• Evidence or history of clinically significant findings at screening

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food
• Therapeutic Equivalency

Intervention

Drug:
• Fesoterodine
Single dose of 2 x 4 mg tab in formulation F under fed condition
• Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fed condition
• Fesoterodine
Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
• Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fed condition
• Fesoterodine
Single dose of 2 x 4 mg tab in formulation F under fasted condition
• Fesoterodine
Single dose of 1 x 8 mg tab in formulation F under fasted condition

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 1 and 2	No
Primary	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		Day 1 and 2	No
Primary	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)		Day 1 and 2	No
Secondary	Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment		Day 1 and 2	No
Secondary	AUCt and Cmax after single oral administration of 8 mg fesoterodine SR tablets of formulation F under fed condition in cohort II		Day 1 and 2	No

External Links

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