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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Therapeutic Equivalency, Food

Intervention / Treatment
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* Drug: Fesoterodine
* Drug: Fesoterodine
* Drug: Fesoterodine
* Drug: Fesoterodine
* Drug: Fesoterodine
* Drug: Fesoterodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese healthy male subject Exclusion Criteria: Evidence or history of clinically significant findings at screening

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence, food effect