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A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.
Subjects will be randomized to one of six treatment sequences. The treatments will be separated by a minimum of 13 days between dosing.
Study drug will be administered after an overnight fast, and food will be restricted for an additional four hours after dosing. Except for the water provided with dosing, water will be restricted only during the hour before and the hour after dosing.
Subjects will stay at the study site for the first three days of each treatment period. Subjects will return to the study center each morning at the same time of the day for Days 4 through 11 of each study period for the pharmacokinetic blood draw and vital signs. Subjects will be in the study for at least 40 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
| |
| Treatment T | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin Succinate Formulation A | Drug | oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment of AUC and maximum concentration (Cmax) through the analysis of blood samples | Up to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
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| Solifenacin Succinate Formulation B | Drug | oral suspension |
|
|
| Solifenacin Succinate | Drug | oral tablet |
|
|
| 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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