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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: APRISO 375 mg extended-release capsules; Drug: Apriso 0.375G ER CAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03327558

VLU-P6-774

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Apriso 0.375G ER CAP

Experimental group

Description:

Apriso 0.375G ER Cap

Treatment:

Drug: Apriso 0.375G ER CAP

APRISO 375 mg extended-release capsules

Active Comparator group

Description:

APRISO 375 mg ER cap

Treatment:

Drug: APRISO 375 mg extended-release capsules