Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Phase 1
Completed
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT03327558
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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 site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APRISO 375 mg extended-release capsules APRISO 375 mg extended-release capsules APRISO 375 mg ER cap Apriso 0.375G ER CAP Apriso 0.375G ER CAP Apriso 0.375G ER Cap
- Primary Outcome Measures
Name Time Method Cmax (Maximum observed plasma concentration) 3 hours after oral dose is taken Maximum observed plasma concentration levels used for descriptive analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Valeant Site 01
🇺🇸San Diego, California, United States