Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

A Phase I, Open-label, Randomized, Single-center, 2-way Crossover Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination Capsule of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg

The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.

Inclusion Criteria:

• Healthy adults who provide informed consent prior to any study-related procedures. Females must be of non-child bearing potential.
• Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion Criteria:

• Recent history of any clinically significant illness as judged by the Investigator within two weeks prior to enrolling in the study
• History of heart, kidney, liver. or gastrointestinal disease considered to be significant as judged by the Investigator
• Moderate to heavy smoking or other nicotine use (greater than 10 cigarettes per day or corresponding amount of nicotine)