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

• Status: Completed
• Trial end date: 2017-08-18
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate and compare the bioavailability of mesalamine

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Mesalamine

Criteria

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