Back to resultsRandomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apriso 0.375G ER CAP
APRISO 375 mg extended-release capsules
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
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
Sites / Locations
- Valeant Site 01
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apriso 0.375G ER CAP
APRISO 375 mg extended-release capsules
Arm Description
Apriso 0.375G ER Cap
APRISO 375 mg ER cap
Outcomes
Primary Outcome Measures
Cmax (Maximum observed plasma concentration)
Maximum observed plasma concentration levels used for descriptive analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT03327558
First Posted
October 26, 2017
Last Updated
May 2, 2018
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03327558
Brief Title
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
August 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apriso 0.375G ER CAP
Arm Type
Experimental
Arm Description
Apriso 0.375G ER Cap
Arm Title
APRISO 375 mg extended-release capsules
Arm Type
Active Comparator
Arm Description
APRISO 375 mg ER cap
Intervention Type
Drug
Intervention Name(s)
Apriso 0.375G ER CAP
Intervention Description
ER capsule
Intervention Type
Drug
Intervention Name(s)
APRISO 375 mg extended-release capsules
Intervention Description
375 mg extended-release capsules
Primary Outcome Measure Information:
Title
Cmax (Maximum observed plasma concentration)
Description
Maximum observed plasma concentration levels used for descriptive analysis
Time Frame
3 hours after oral dose is taken
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Valeant Site 01
City
San Diego
State/Province
California
ZIP/Postal Code
22434
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
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