Healthy
Conditions
Brief summary
To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.
Interventions
DRUGBIBR 1048 MS
BIBR 1048 MS capsule 150 mg
DRUGPantoprazole
Pantoprazole tablet 40 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female elderly subjects as determined by results of screening * Signed written informed consent in accordance with GCP and local legislation * Age ≥ 65, no upper limit * 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 * Clinically relevant 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) * cranio-cerebral trauma * 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 intake (\>30 - 40 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 \< 140000/μl (male) or \< 156000/μl (female)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| t½,ss (terminal half-life, calculated from the terminal elimination rate constant) | Day 4 and 7 |
| AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state) | Day 4 and 7 |
| Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ) | Day 4 and 7 |
| Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state) | Day 4 and 7 |
| feτ,ss (percent of dose excreted in urine over one dosing interval at steady state) | Day 4 and 7 |
| AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz)) | Day 4 and 7 |
| Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ) | Day 4 and 7 |
| tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ) | Day 4 and 7 |
Secondary
| Measure | Time frame |
|---|---|
| MRTss (steady state mean residence time) | Day 4 and 7 |
| CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration) | Day 4 and 7 |
| Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) | Day 4 and 7 |
| Changes in activated partial thromboplastin time (aPTT) | Day 4 and 7 |
| Changes in ecarin clotting time (ECT) | Day 4 and 7 |
| Occurrence of Adverse Events | up to 10 days |
| CLR,ss (renal clearance at steady state following multiple dose administration) | Day 4 and 7 |
Outcome results
None listed