Healthy
Conditions
Brief summary
Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.
Interventions
DRUGTerbogrel
DRUGClopidogrel
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 findings 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 or hormonal disorders * History of orthostatic hypotension, fainting spells or 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 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 days 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 (\> 60 g/day) abuse * 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 reference range of clinical relevance * History of any familial bleeding disorder * Thrombocytes \< 150000/µl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inhibition of platelet aggregation in platelet rich plasma (PRP) | baseline, up to day 17 |
| Change in thromboxane receptor occupancy (TRO) | baseline, up to day 17 |
| Change in 6-keto-prostaglandinF-1-alpha | baseline, up to day 17 |
| Change in thromboxan synthesis inhibition (TSI) | baseline, up to day 17 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pulse rate | baseline, up to day 17 | — |
| Number of patients with haematuria | up to day 17 | dipstick test |
| Plasma levels of terbogrel | up to day 17 | — |
| Number of patients with clinically significant laboratory findings | up to day 17 | — |
| Number of patients with positive Haemoccult test | up to day 17 | — |
| Number of patients with adverse events | up to day 17 | — |
| Change in bleeding time | baseline, up to day 17 | — |
| Change in systolic and diastolic blood pressure | baseline, up to day 17 | — |
Outcome results
None listed