PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

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.

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 Investigator: Salix Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Audrey Shaw, PhD Study Director Salix Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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