Overview

Clopidogrel And Ticagrelor in Healthy Subjects

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
Male
Summary
To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dong-A University
Treatments:
Adenosine
Clopidogrel
Polystyrene sulfonic acid
Ticagrelor
Ticlopidine
Criteria
Inclusion Criteria:

- 12 healthy men

- Aged between 19 and 59 years

- Body mass index (BMI) is between 18.5 and 29.9 kg/m2

- Baseline maximal platelet aggregation (MPA) 10 μmol/L ADP is more than 65%

- To screen for standard results on usual clinical tests

Exclusion Criteria:

- A history of bleeding within 6 months

- Bleeding diathesis

- Hemoglobin < 12g/dl

- History of antiplatelet or anticoagulation treatment within 1 month

- contraindication to the study drug

- Severe hepatic dysfunction (serum liver enzyme or bilirubin >3 times normal limit)

- Patients with hereditary disease such as galactose intolerance, lactase deficiency,
glucose-galactose malabsorption

- Previous experience of clinical trials within three months