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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001248-39 | EudraCT Number |
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The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine ER (fasted) | Drug | Commercial Fesoterodine ER 4 mg (single dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 48 hours |
| Maximum Observed Plasma Concentration (Cmax) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 48 hours |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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 Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Fesoterodine SR3 (fasted) |
| Drug |
Fesoterodine SR3 4 mg (single dose) |
|
| Fesoterodine SR3 (fed) | Drug | Fesoterodine SR3 4 mg (single dose) with high-fat meal |
|
| Fesoterodine ER (fed) | Drug | Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal |
|
| Fesoterodine SR3 (sprinkle) | Drug | Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce |
|
| Fesoterodine ER (fasted) | Drug | Commercial Fesoterodine ER 4 mg (single dose) |
|
| Fesoterodine SR4 (fasted) | Drug | Fesoterodine SR4 4 mg (single dose) |
|
| Fesoterodine SR4 (fed) | Drug | Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal |
|
| Fesoterodine ER (fed) | Drug | Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal |
|
| Fesoterodine SR4 (sprinkle) | Drug | Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce |
|
| 48 hours |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 48 hours |
| ID | Term |
|---|---|
| C526675 | fesoterodine |
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