Healthy
Conditions
Brief summary
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.
Interventions
DRUGBIBR 1048 MS
Low, medium or high dose
DRUGRanitidine
150mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male subjects as determined by results of screening * signed written informed consent in accordance with GCP and local legislation * age \>= 18 and \<= 50 years * Broca \>= - 20% and \<0 + 20%
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: * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * any bleeding disorder including prolonged or habitual bleeding * other hematologic disease * cerebral bleeding (e.g. after a car accident) * commotio cerebri * 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Changes from baseline in routine laboratory | baseline up to 36 h after last administration |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | 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 |
Outcome results
None listed