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OpenTrials
Completed

NCT Number: NCT03327558

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

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

Completed

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Valeant Site 01

San Diego, California, 22434, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apriso 0.375G ER CAP

Drug

ER capsule

APRISO 375 mg extended-release capsules

Drug

375 mg extended-release capsules

Primary outcomes

  1. Cmax (Maximum observed plasma concentration)

    Time frame: 3 hours after oral dose is taken

    Maximum observed plasma concentration levels used for descriptive analysis

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2017
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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