Expired Study
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Dallas, Texas 75247


Purpose:

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.


Criteria:

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


NCT ID:

NCT00622375


Primary Contact:

Study Director
Audrey Shaw, PhD
Salix Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75247
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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