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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (Cohort I) | Experimental |
| |
| B (Cohort I) | Experimental |
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| C (Cohort I) | Experimental |
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| B (Cohort II) | Experimental |
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| D (Cohort II) | Experimental |
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| E (Cohort II) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | Single dose of 2 x 4 mg tab in formulation F under fed condition |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Fesoterodine |
| Drug |
Single dose of 1 x 8 mg tab in formulation F under fed condition |
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| Fesoterodine | Drug | Single dose of 1 x 8 mg tab in formulation E(1) under fed condition |
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| Fesoterodine | Drug | Single dose of 1 x 8 mg tab in formulation F under fed condition |
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| Fesoterodine | Drug | Single dose of 2 x 4 mg tab in formulation F under fasted condition |
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| Fesoterodine | Drug | Single dose of 1 x 8 mg tab in formulation F under fasted condition |
|