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The purpose of the study is to investigate whether orally administered BAX 513 (different doses administered for 5 days) affects hemostatic parameters in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAX 513 | Experimental | Capsule - one of 5 dose levels (per randomization) - BID (= twice a day) |
|
| Capsule (cellulose) | Placebo Comparator | Capsule - one of 5 dose levels (per randomization) - BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fucoidan (extract of Laminaria japonica) | Other | Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA). | 7 months (= anticipated study duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic for Clinical Pharmacology, General Hospital Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| C007789 | fucoidan |
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| Placebo | Other | Cellulose filled capsule - oral administration - 5 different dose levels - BID |
|