NCT03327558

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Apriso 0.375G ER CAP	ER capsule
DRUG	APRISO 375 mg extended-release capsules	375 mg extended-release capsules

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-06-23
• Completion: 2017-08-18
• First posted: 2017-10-31
• Last updated: 2018-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study