Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
NCT03327558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2018-05-08
Summary
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Conditions
Interventions
- DRUG
-
Apriso 0.375G ER CAP
ER capsule
- DRUG
-
APRISO 375 mg extended-release capsules
375 mg extended-release capsules
Sponsors & Collaborators
-
Bausch Health Americas, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-15
- Primary Completion
- 2017-06-23
- Completion
- 2017-08-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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