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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00807118

Collaborator

(none)

108

Enrollment

Location

Arms

Duration (Months)

53.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Equivalency Food	Drug: Fesoterodine Drug: Fesoterodine Drug: Fesoterodine Drug: Fesoterodine Drug: Fesoterodine Drug: Fesoterodine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 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-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.

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A (Cohort I)	Drug: Fesoterodine Single dose of 2 x 4 mg tab in formulation F under fed condition
Experimental: B (Cohort I)	Drug: Fesoterodine Single dose of 1 x 8 mg tab in formulation F under fed condition
Experimental: C (Cohort I)	Drug: Fesoterodine Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
Experimental: B (Cohort II)	Drug: Fesoterodine Single dose of 1 x 8 mg tab in formulation F under fed condition
Experimental: D (Cohort II)	Drug: Fesoterodine Single dose of 2 x 4 mg tab in formulation F under fasted condition
Experimental: E (Cohort II)	Drug: Fesoterodine Single dose of 1 x 8 mg tab in formulation F under fasted condition

Outcome Measures

Primary Outcome Measures

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]
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]
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]

Secondary Outcome Measures

Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment [Day 1 and 2]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Japanese healthy male subject

Exclusion Criteria:

Evidence or history of clinically significant findings at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Shinjuku-ku	Tokyo	Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00807118

Other Study ID Numbers:

A0221052

First Posted:

Dec 11, 2008

Last Update Posted:

Mar 24, 2010

Last Verified:

Mar 1, 2010

Keywords provided by , ,

bioequivalence, food effect

Additional relevant MeSH terms:

Fesoterodine

Study Results

No Results Posted as of Mar 24, 2010