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To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBR 1048 MS with ranitidine | Experimental | Low, medium or high dose in combination with ranitidine |
|
| BIBR 1048 MS without ranitidine | Experimental | Low, medium or high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBR 1048 MS | Drug | Low, medium or high dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h) | before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment | |
| Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf) | before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of drug in plasma ( Cmax ) | before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment | |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
any finding of the medical examination (including blood pressure, pulse rate and ECG)
history or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
history of orthostatic hypotension, fainting spells and blackouts
diseases of central nervous system (such as epilepsy) or psychiatric disorders
chronic or relevant acute infections
History of:
intake of drugs with a long half-life (>24 hours) within 1 month prior to administration
use of any drugs which might influence the results of the trial within 10 days prior to administration or during administration
participation in another trial with an investigational drug within 2 month prior to administration or during trial
smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
alcohol abuse (>60 g / day)
drug abuse
blood donation within 1 month prior to administration or during the trial
excessive physical activities within 5 days prior to administration or during the trial
any laboratory value outside the clinically accepted reference range
history of any familial bleeding disorder
Thrombocytes < 150000 /µl
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| ID | Term |
|---|---|
| D011899 | Ranitidine |
| ID | Term |
|---|---|
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ranitidine | Drug | 150mg |
|
|
| before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment |
| Changes from baseline in Pulse rate | baseline up to 36 h after last administration |
| Changes from baseline in blood pressure (systolic and diastolic) | baseline up to 36 h after last administration |
| Changes from baseline in ECG | baseline up to 36 h after last administration |
| Changes from baseline in routine laboratory | baseline up to 36 h after last administration |
| Number of participants with adverse events | up to 36 h after last administration |
| Changes in international normalized ratio (INR ) | before and 2 hours after treatment |
| Changes in activated prothrombin time (aPTT) | before and 2 hours after treatment |