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The objective of the study is to compare the relative bioavailability and pharmacokinetics of solifenacin succinate suspension versus tablet.
All subjects will participate in each treatment separated by a minimum (=> minimum) of 13 days between dosing.
In the two fasting periods, each subject will receive solifenacin succinate orally in each treatment period following a minimum 10 hour fast from food and beverages. In the fed condition, each subject will receive the suspension within 30 minutes of the start of breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solifenacin succinate tablet (fasting) | Active Comparator |
| |
| solifenacin succinate suspension (fasting) | Experimental |
| |
| solifenacin succinate suspension (fed) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin succinate suspension | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum solifenacin succinate pharmacokinetics (PK) parameters | Periods 1, 2 and 3 Days 1-11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Bend | Wisconsin | 53095 | United States |
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| solifenacin succinate tablet | Drug | Oral |
|
|
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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