Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

The objective of this study is to evaluate and compare the bioavailability of mesalamine and
therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule
manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after
a single oral dose administration under fasting conditions.

Inclusion Criteria:

- Healthy male or female, at least 18 years of age

- Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)

- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, ECG and laboratory tests

Exclusion Criteria:

- Any contraindication to mesalamine according to the applicable labeling