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To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lefradafiban with clopidogrel | Experimental | All patients received the same treatment:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lefradafiban | Drug |
| ||
| Clopidogrel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Amount of the analyte excreted unchanged in the urine (Ae) | Up to 176:00 hours after first drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 5 days after last drug administration | |
| Changes from baseline in 12-lead ECG | Pre-dose and 384:30 hours after first drug administration | |
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Inclusion Criteria:
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
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
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| ID | Term |
|---|---|
| C107918 | lefradafiban |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| Number of subjects with clinically significant findings in vital signs |
systolic and diastolic blood pressure, pulse rate |
| up to 5 days after last drug administration |
| Changes from baseline in bleeding time | Pre-dose and 384:30 hours after first drug administration |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |