Influence of Clopidogrel on the Pharmacodynamics and Safety of Terbogrel in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
Study to assess the influence of 75 mg clopidogrel on the pharmacodynamics and safety of 100 mg terbogrel bid.

Official Title
-----------------
Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Oral Doses of 100 mg Terbogrel Bid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Terbogrel
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terbogrel<br> | Drug: Terbogrel<br> <br> |
| Experimental: Terbogrel with Clopidogrel<br> | Drug: Terbogrel<br> <br> Drug: Clopidogrel<br> <br> |
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of terbogrel |  | 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 | 
| Change in pulse rate |  | baseline, up to day 17 | 
| Number of patients with haematuria | dipstick test | up to day 17 | 
| Number of patients with positive Haemoccult test |  | up to day 17 | 
| Number of patients with clinically significant laboratory findings |  | up to day 17 |