Healthy
Conditions
Brief summary
To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
Interventions
DRUGClopidogrel
DRUGLefradafiban
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent in accordance with good clinical practice (GCP) and local legislation * Healthy male subjects * Age ≥ 18 and ≤ 45 years * Broca ≥ - 20 % and ≤ + 20 %
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance * History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders * 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 which 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 the 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 |
|---|---|
| Amount of the analyte excreted unchanged in the urine (Ae) | Up to 176:00 hours after first drug administration |
| Inhibition of platelet aggregation in platelet rich plasma (PRP) | Up to 383:30 hours after first drug administration |
| Fibrinogen receptor occupancy levels (FRO) | Up to 383:30 hours after first drug administration |
| Maximum concentration of the analyte in plasma at steady state (Cmax) | Up to 383:30 hours after first drug administration |
| Area under the concentration-time curve of the analyte in plasma (AUC) | Up to 383:30 hours after first drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in 12-lead ECG | Pre-dose and 384:30 hours after first drug administration | — |
| Number of subjects with clinically significant findings in vital signs | up to 5 days after last drug administration | systolic and diastolic blood pressure, pulse rate |
| Changes from baseline in bleeding time | Pre-dose and 384:30 hours after first drug administration | — |
| Number of subjects with adverse events | up to 5 days after last drug administration | — |
Outcome results
None listed