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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03327558 on ClinicalTrials.gov