Healthy
Conditions
Brief summary
Study to assess the amount of BIBR 953 ZW in urine and concentrations in plasma after administration of 50 mg of BIBR 1048 bid over three days each administered as two experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole.
Interventions
DRUGBIBR 1048 MS Capsule I
25 mg BIBR 1048 MS
DRUGBIBR 1048 MS Capsule K
50 mg BIBR 1048 MS
DRUGPantoprazole
40 mg pantoprazole
50 mg BIBR 1048 MS powder plus solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 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 ≤ 55 years * BMI ≥ 18.5 and ≤ 29.9 kg/m2
Exclusion criteria
* Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders * History of relevant 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 * 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 that might influence the results of the trial within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within 2 months 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 |
|---|---|
| Total amount of BIBR 953 ZW excreted into urine during one dosing interval (Ae0-12) | Day 1 to day 10 |
| AUCss (Area under the plasma concentration-time curve at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period |
| tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW | 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours after administration of study drug on day 3 of second treatment period |
Outcome results
None listed