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To investigate the bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate plus digoxin | Experimental |
| |
| Dabigatran etexilate | Active Comparator |
| |
| Digoxin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug |
| ||
| Digoxin |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) | Up to 72 hours after drug administration on day 4 | |
| Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) | 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ (AUC0-tz,ss) | Up to 72 hours after drug administration on day 4 | |
| Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss) |
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Inclusion Criteria:
Healthy males and females according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Age ≥18 and ≤65 years
BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Drug |
|
| Up to 72 hours after drug administration on day 4 |
| Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | Up to 72 hours after drug administration on day 4 |
| Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss) | Up to 72 hours after drug administration on day 4 |
| Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss) | Up to 24 hours after drug administration on day 4 |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) | Up to 72 hours after drug administration on day 4 |
| Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ ( tmin,ss) | Up to 72 hours after drug administration on day 4 |
| Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) | 2 hours before drug administration on day 4 |
| Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss) | Up to 72 hours after drug administration on day 4 |
| Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss) | Up to 24 hours after drug administration on day 4 |
| Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad) | Day 76 |
| Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss) | Up to day 7 |
| Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss) | Up to 24 hours after drug administration on day 4 |
| Area under the effect ratio curve (AUERτ,ss) for activated prothrombin time (aPTT) and ecarin clotting time (ECT) | Up to 72 hours after drug administration on day 4 |
| Prolongation at trough (ERpre,ss) for aPTT | Up to 72 hours after drug administration on day 4 |
| Change from baseline in physical examination | Baseline, day 76 |
| Change from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 76 |
| Change from baseline in 12-lead electrocardiogram | Baseline, day 76 |
| Change from baseline in clinical laboratory tests | Baseline, day 76 |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to day 76 |
| Maximum effect ratio at steady state (ERmax,ss) for aPTT and ECT | Up to 72 hours after drug administration on day 4 |
| Prolongation at trough (ERpre,ss) for ECT | Up to 72 hours after drug administration on day 4 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |