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NCT03327558 Clinical Trial

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

Ulcerative Colitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03327558
Other study ID # VLU-P6-774
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 15, 2017
Est. completion date August 18, 2017

Study information
Verified date May 2018
Source Valeant Pharmaceuticals International, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date August 18, 2017
Est. primary completion date June 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Apriso 0.375G ER CAP
ER capsule
• APRISO 375 mg extended-release capsules
375 mg extended-release capsules

Locations
Country Name City State
United States Valeant Site 01 San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Valeant Pharmaceuticals International, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax (Maximum observed plasma concentration) Maximum observed plasma concentration levels used for descriptive analysis 3 hours after oral dose is taken
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