Healthy
Conditions
Brief summary
Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects as determined by results of screening * Signed written informed consent in accordance with good clinical practice (GCP) and local legislation * Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects) * Broca ≥ - 20 % and ≤ + 20 %
Exclusion criteria
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial * Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration * Participation in another trial with an investigational drug within 2 months prior to administration or during the trial * Drug abuse * Alcohol abuse (\> 60 g/day) * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days * Excessive physical activities within 5 days prior to administration or during the trial * Blood donation within 1 month prior to administration or during the trial * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders * Chronic or relevant acute infections * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * 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) * Recent surgical procedures * Thrombocytes \< 150000/µ * Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * Any laboratory value outside the clinically accepted reference range * Other disease or abnormality of clinical relevance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state, 13th dosing interval (AUCss,13) | Up to 168 hours after first drug administration |
| Maximum concentration of the analyte in plasma at steady state, 13th dosing interval (Cmax,ss,13) | Up to 168 hours after first drug administration |
| Pre-dose concentration of the analyte in plasma at steady state, 13th dosing interval (Cpre,ss,13) | Up to 168 hours after first drug administration |
| Amount of the analyte eliminated unchanged in the urine per dosing interval (Ae% (i=1,...,13)) | Up to 168 hours after first drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent peak-trough fluctuation for the 13th dosing interval (%PTF13) | Up to 168 hours after first drug administration | Calculated: (Cmax,ss,13 - Cpre,ss,13) \* 8h / AUCss,13 \* 100%) |
| Percent fluctuation of area under the plasma concentration-time curve (AUCfluc,13) | Up to 168 hours after first drug administration | Calculated: (AUCabove,13 - AUCbelow,13) / AUCabove,13 |
| Fibrinogen receptor occupancy levels | Up to 168 hours after first drug administration | — |
| Pre-dose concentration lf the analyte in plasma for the i-th dosing interval (Cpre,i (i=1,4,7,10,11,12)) | Up to 168 hours after first drug administration | — |
| Number of subjects with clinically significant findings in vital signs | Up to 3 days after last drug administration | systolic and diastolic blood pressure, pulse rate |
| Number of subjects with clinically significant findings in laboratory tests | Up to 3 days after last drug administration | — |
| Number of subjects with adverse events | Up to 3 days after last drug administration | — |
| Plasma concentration of the analyte at 2 hours post-dose for the i-th dosing interval (C2h,i (i=10,11,12)) | up to 2 hours after each dosing interval | — |
| Terminal half life of the analyte in plasma (t1/2) | Up to 168 hours after first drug administration | — |
| Percent swing of peak/trough concentrations of the analyte in plasma for the i-th dosing interval (%Swing,i) | Up to 168 hours after first drug administration | Calculated: (C2h,i - Cpre,i) / Cpre,i \* 100% (i=10,11,12) |
Outcome results
None listed