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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005090-11 | EudraCT Number |
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The main purpose is to study the pharmacokinetics of aprocitentan (ACT-132577) using 2 different tablet formulations. The clinical pharmacology data will be used to determine bioequivalence of 2 different tablet formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprocitentan (reference product) | Experimental | 25 mg film-coated tablet |
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| Aprocitentan (test product) | Experimental | 25 mg film-coated tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprocitentan (Formulation A) | Drug | A single oral dose of 25 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of aprocitentan | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10. | |
| The area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of aprocitentan | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10. | |
| Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of aprocitentan | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | From study treatment administration on Day 1 up to last assessment at End of Period (Day 10). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEPHA s.r.o. | Pilsen | 323 00 | Czechia |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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| Aprocitentan (Formulation B) | Drug | A single oral dose of 25 mg. |
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