PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

mesalamine

Intervention Type DRUG

encapsulated mesalamine granules

Interventions

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mesalamine

encapsulated mesalamine granules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes