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This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, Cohort 1 | Experimental |
| |
| Treatment B, Cohort 2 | Experimental |
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| Treatment C, Cohort 1 | Experimental |
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| Treatment D, Cohort 2 | Experimental |
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| Treatment E, Cohort 1 and/or Cohort 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine fumarate | Drug | One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | |
| Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. |
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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 | Singapore | Singapore | 188770 | Singapore |
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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 fumarate | Drug | One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose |
|
| fesoterodine fumarate | Drug | One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose |
|
| fesoterodine fumarate | Drug | One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose |
|
| fesoterodine fumarate | Drug | one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose |
|
| Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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