Pharmacodynamic Study of Cilostazol in Healthy Volunteers

Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers

The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.

Inclusion Criteria:

• Healthy Caucasian male subjects
• Able to read, to write and to fully understand German language
• Provision of written informed consent before screening and baseline
• BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
• Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion Criteria:

• Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
• Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
• Use of antibiotics within thirty (30) days prior to screening and until baseline visit
• Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
• Supine pulse rate > 100 beats/min or <50 beats/min
• Systolic blood pressure <100 or >140 mmHg
• Diastolic blood pressure <50 or >90 mmHg
• Concomitant use of any other medication including over-the-counter preparations