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

Completed · Phase 1

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT03327558

Run by

Bausch Health Americas, Inc.

People needed

60

Starts

2017-05-15

Expected to finish

2017-08-18

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Any contraindication to mesalamine according to the applicable labeling

Where it is running

• Valeant Site 01 — San Diego, California, United States

Full record on ClinicalTrials.gov

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