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To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters prior to administration of a high dose of dabigatran etexilate in a QT study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate low dose | Experimental |
| |
| Dabigatran etexilate medium dose | Experimental |
| |
| Dabigatran etexilate high dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate low dose | Drug |
| ||
| Dabigatran etexilate medium dose |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency [N (%)] of subjects with adverse events | up to 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma) | up to 72 hours after administration | |
| tmax (time from dosing to maximum measured concentration) | up to 72 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Dabigatran etexilate high dose | Drug |
|
| Placebo | Drug |
|
| AUC0-∞ (area under the concentration-time curve of free and total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity) | up to 72 hours after administration |
| λz (terminal rate constant in plasma) | up to 72 hours after administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 72 hours after administration |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 72 hours after administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 72 hours after administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 72 hours after administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 72 hours after administration |
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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