Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
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
1 other identifier
interventional
60
1 country
1
Brief Summary
The objective of this study is to evaluate and compare the bioavailability of mesalamine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2017
CompletedFirst Submitted
Initial submission to the registry
October 26, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedMay 8, 2018
May 1, 2018
1 month
October 26, 2017
May 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cmax (Maximum observed plasma concentration)
Maximum observed plasma concentration levels used for descriptive analysis
3 hours after oral dose is taken
Study Arms (2)
Apriso 0.375G ER CAP
EXPERIMENTALApriso 0.375G ER Cap
APRISO 375 mg extended-release capsules
ACTIVE COMPARATORAPRISO 375 mg ER cap
Interventions
375 mg extended-release capsules
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any contraindication to mesalamine according to the applicable labeling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Valeant Site 01
San Diego, California, 22434, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2017
First Posted
October 31, 2017
Study Start
May 15, 2017
Primary Completion
June 23, 2017
Study Completion
August 18, 2017
Last Updated
May 8, 2018
Record last verified: 2018-05