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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807118

Enrollment

108

Registered

2008-12-11

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2010-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food, Therapeutic Equivalency

Keywords

bioequivalence, food effect

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.

Interventions

DRUGFesoterodine

Single dose of 2 x 4 mg tab in formulation F under fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Japanese healthy male subject

Exclusion criteria

* Evidence or history of clinically significant findings at screening

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026