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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015762-64 | EudraCT Number |
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The primary objective of this study is to evaluate whether naproxen and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm A | Experimental | darexaban, wash-out, naproxen, wash-out, combination therapy |
|
| Treatment arm B | Experimental | darexaban, wash-out, combination therapy, wash-out, naproxen |
|
| Treatment arm C | Experimental | naproxen, wash-out, darexaban, wash-out, combination therapy |
|
| Treatment arm D | Experimental | naproxen, wash-out, combination therapy, wash-out, darexaban |
|
| Treatment arm E | Experimental | combination therapy, wash-out, naproxen, wash-out, darexaban |
|
| Treatment arm F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darexaban | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacodynamics of naproxen | Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacodynamics of darexaban | Baseline and 3 hours after multiple dosing (darexaban: 6 days, naproxen: 4 days) of darexaban, naproxen, or a combination of the two | |
| Pharmacokinetics of darexaban assessed by plasma concentration | Plasma samples are taken until 24 hours after six days of dosing of darexaban, or the combination with naproxen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Principal Investigator | SGS Aster, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Aster | Paris | 75015 | France |
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| ID | Term |
|---|---|
| C569750 | darexaban |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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combination therapy, wash-out, darexaban, wash-out, naproxen
|
|
| Naproxen | Drug | oral |
|
|
| Pharmacokinetics of naproxen assessed by plasma concentration | Plasma samples are taken until 12 hours after four days of dosing of naproxen, or the combination with darexaban |
| Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events | 6 days (for treatment periods with darexaban) or 4 days. (naproxen alone) |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |