Pharmacodynamic Study of Cilostazol in Healthy Volunteers (NCT02554721) | Clinical Trial Compass
CompletedPhase 1
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Germany77 participantsStarted 2015-08
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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