Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Inclusion Criteria:

• Body mass index of 19-29kg/m2, inclusive
• Weight of 50-95kg, inclusive
• Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion Criteria:

• Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
• History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
• Condition which could modify the absorption of the investigational products, as judged by the Investigator