Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

Bausch Health Americas, Inc.60 enrolled

Overview

The objective of this study is to evaluate and compare the bioavailability of mesalamine

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

Apriso 0.375G ER CAPDRUG

ER capsule

APRISO 375 mg extended-release capsulesDRUG

375 mg extended-release capsules

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Valeant Site 01

San Diego, California, United States

Outcomes

Primary Outcomes

Cmax (Maximum observed plasma concentration)

Maximum observed plasma concentration levels used for descriptive analysis

Time frame: 3 hours after oral dose is taken

Data from ClinicalTrials.gov

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