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This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | Experimental | Single 150-mg dose of dabigatran etexilate |
|
| Rivaroxaban | Experimental | Single 20-mg dose of rivaroxaban |
|
| No intervention | No Intervention | No study drug will be administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay | From up to 2 hours pre-dose to up to 24 hours post-dose | |
| Level of fibrin degradation product (D-dimer) | From up to 2 hours pre-dose to up to 24 hours post-dose | |
| Level of fibrinopeptide A (FPA) | From up to 2 hours pre-dose to up to 24 hours post-dose | |
| Level of prothrombin split products (F1+2) | From up to 2 hours pre-dose to up to 24 hours post-dose | |
| Level of thrombin-antithrombin complex (TAT) | From up to 2 hours pre-dose to up to 24 hours post-dose |
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Inclusion criteria for non-hemophilia participants:
Panel A
- Male or female between 65 to 85 years of age
Panel B
- Male between 18 to 45 years of age
Both Panels
Exclusion criteria for non-hemophilia participants:
Inclusion criteria for hemophilia participants:
Exclusion criteria for hemophilia participants:
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| rivaroxaban | Drug | rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration |
|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |