PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: mesalamine

• Registration Number: NCT00622375
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-02
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Study Completion: 2008-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• The subject is Male, or female of Non-childbearing potentia.l
• The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control.
• The subject is between the ages of 18 and 45 years.
• The subject has a body mass index (BMI) between 18 and 32 kg/m2 (weight/[height]).

Exclusion Criteria

• The subject is seropositive for human immunodeficiency virus (HIV),hepatitis B surface antigen, and/or hepatitis C virus.
• The subject has any clinically significant medical, social, or emotional problem.
• The subject is pregnant or lactating
• The subject has a history of clinically significant renal, hepatic,endocrine, oncological,gastrointestinal, or cardiovascular disease or a history of epilepsy, asthma, diabetes mellitus, psychosis, glaucoma, or severe head injury.
• The subject is currently receiving mesalamine or aspirin containing products
• The subject has a history of viral, bacterial, or fungal infection within 4 weeks of screening.
• The subject has an acute illness within 1 week of study-drug administration.
• The subject has an abnormal nutritional status, including unconventional, alternative,and abnormal diets; excessive or unusual vitamin intake; malabsorption; psychological eating disorders; difficulty swallowing medication; significant recent weight change; etc.
• The subject has clinically significant allergies.
• The subject has a hypersensitivity or allergy to mesalamine or other salicylate.
• The subject has known or suspected alcohol abuse or illicit drug use within the past year
• The subject has used tobacco (or nicotine products) during the 6 months prior to screening
• The subject has participated in an investigational drug study within the 30 days before receiving study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	mesalamine	-

Primary Outcome Measures

Name	Time	Method
Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics	14 days