Healthy
Conditions
Brief summary
To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.
Interventions
DRUGBIBR 1048 MS - low dose
DRUGBIBR 1048 MS - high dose
DRUGBIBR 1048 MS + Pantoprazole
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 ≤ + 20%
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * History of orthostatic hypotension, fainting spells and blackouts * Diseases of the 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 * History of any bleeding disorder including prolonged or habitual bleeding * History of other hematologic disease * History of cerebral bleeding (e.g. after a car accident) * History of commotio cerebri * Intake of drugs with a long-life (\> 24 hours) within 1 month prior to administration * Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial * Participation in another trial with investigational drug within 2 months prior to administration or during the trial * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Alcohol abuse (\> 60g/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 familiar bleeding disorder * Thrombocytes \< 150000/µl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary excretion of total BIBR 953 ZW | Day 1, day 2, day 3 (different time points) |
| Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW | Day 1, day 2, day 3 (different time points) |
| Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW | Day 1, day 2, day 3 (different time points) |
| Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval | Day 1, day 2, day 3 (different time points) |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in systolic and diastolic blood pressure | Baseline, day 1,day 2, day 3, day 4 |
| Change from Baseline in clinical laboratory tests | Baseline, day 1,day 2, day 3, day 4 |
| Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW | Day 1, day 2, day 3 (different time points) |
| Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR)) | Day 1, day 2, day 3 (different time points) |
| Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration | ay 1, day 2, day 3 (different time points) |
| Changes from baseline in activated partial thromboplastin time (aPTT) | Day 1, day 2, day 3 (different time points) |
| Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration | Day 1, day 2, day 3 (different time points) |
| Occurence of adverse events | 6 weeks |
| Change from Baseline in pulse rate | Baseline, day 1,day 2, day 3, day 4 |
Outcome results
None listed