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This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban and Clarithromycin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Multiple-dose clarithromycin and single-dose Apixaban |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Days 1-11 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Days 1-11 | |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Days 1-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death | Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Llc | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31030414 | Derived | Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B. The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study. Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin |
| Drug |
Multiple-dose clarithromycin and single-dose Apixaban |
|
| Organic Chemicals |