PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

NCT00622375 | Completed Phase 1

• 1 other identifier: MPPK1003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetic study; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics

  14 days

Study Arms (1)

1

EXPERIMENTAL

Drug: mesalamine

Interventions

mesalamine DRUG

encapsulated mesalamine granules

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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/\[height\]).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Unknown Facility

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Mesalamine

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Audrey Shaw, PhD

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)