Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cmax (Maximum observed plasma concentration)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Apriso 0.375G ER CAP
Apriso 0.375G ER Cap
Intervention: Apriso 0.375G ER CAP (Drug)
APRISO 375 mg extended-release capsules
APRISO 375 mg ER cap
Intervention: APRISO 375 mg extended-release capsules (Drug)
Outcomes
Primary Outcomes
Cmax (Maximum observed plasma concentration)
Time Frame: 3 hours after oral dose is taken
Maximum observed plasma concentration levels used for descriptive analysis
Secondary Outcomes
No secondary outcomes reported