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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Single dose of 2 x 4 mg tab in formulation F under fed condition
Single dose of 1 x 8 mg tab in formulation F under fed condition
Single dose of 1 x 8 mg tab in formulation E(1) under fed condition
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
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
Time frame: 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
Time frame: 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)
Time frame: Day 1 and 2
Tmax, AUClast, AUCinf, kel, t1/2 and MRT of all treatment
Time frame: 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
Time frame: Day 1 and 2
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Single dose of 1 x 8 mg tab in formulation F under fed condition
Single dose of 2 x 4 mg tab in formulation F under fasted condition
Single dose of 1 x 8 mg tab in formulation F under fasted condition