An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers

The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.

Inclusion Criteria:

• Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
• Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
• Have a body mass index between 19 and 30 kg/m2 inclusive
• No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion Criteria:

• Any clinically significant abnormalities in laboratory screening results as judged by investigator
• Platelet count <150 x 10^9/L on Day -1 or any other conditions that would increase the risk of bleeding
• Previous bone marrow transplant
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG