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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004925-99 | EudraCT Number |
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The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.
Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cariprazine PR tablet B | Experimental | Cariprazine prolonged release tablet B - fed |
|
| Cariprazine PR tablet A | Experimental | Cariprazine prolonged release tablet A - fed |
|
| Cariprazine capsule | Experimental | Cariprazine capsule - fasted |
|
| Cariprazine prolonged release tablet B | Experimental | Cariprazine prolonged release tablet B - fasted |
|
| Cariprazine prolonged release tablet A | Experimental | Cariprazine prolonged release tablet A - fasted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cariprazine prolonged release tablet A | Drug | Cariprazine prolonged release tablet A - fasted |
|
| Measure | Description | Time Frame |
|---|---|---|
| C[max] | Maximum Serum Concentration of the parent drug | 0-672 hours |
| AUC | Area Under the Serum Concentration-Time Curve of the parent drug | 0-672 hours |
| T[max] | Time to Reach the Maximum Serum Concentration of the parent drug | 0-672 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Other PK parameters of the parent drug | Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable | 0-672 hours |
| PK parameters of the metabolites, if applicable | Maximum Serum Concentration (Cmax), Time to Reach the Maximum Serum Concentration (Tmax), (AUC0-t), Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞), Elimination half-life period (t1/2) and Mean Residence Time (MRT) |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
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| ID | Term |
|---|---|
| C533287 | cariprazine |
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| Cariprazine prolonged release tablet B | Drug | Cariprazine prolonged release tablet B - fasted |
|
| Cariprazine capsule | Drug | Cariprazine capsule - fasted |
|
| Cariprazine PR tablet A | Drug | Cariprazine Prolonged Release tablet A - fed |
|
| Cariprazine PR tablet B | Drug | Cariprazine Prolonged Release tablet B - fed |
|
| 0-672 hours |