Status:
COMPLETED
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Detailed Description
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 si...
Eligibility Criteria
Inclusion
- 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
- Any contraindication to mesalamine according to the applicable labeling
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03327558
Start Date
May 15 2017
End Date
August 18 2017
Last Update
May 8 2018
Active Locations (1)
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1
Valeant Site 01
San Diego, California, United States, 22434