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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03327558
• Date of registration: 26/10/2017
• Prospective Registration: No
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
• Scientific 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
• Date of first enrolment: May 15, 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03327558
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: APRISO 375 mg extended-release capsules

Drug: Apriso 0.375G ER CAP

Primary Outcome(s)

Cmax (Maximum observed plasma concentration) [Time Frame: 3 hours after oral dose is taken]

Secondary ID(s)

VLU-P6-774

Source(s) of Monetary Support

Please refer to primary and secondary sponsors