PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Study Overview
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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.

Official Title
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A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: mesalamine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: mesalamine<br>* encapsulated mesalamine granules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic study, Healthy subjects