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

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.

Study Type: Interventional

Study Design: Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: mesalamine
  • encapsulated mesalamine granules

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Salix Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Audrey Shaw, PhD Study Director Salix Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00622375

Study ID Number: MPPK1003

ClinicalTrials.gov Identifier: NCT00622375

Health Authority: United States: Food and Drug Administration