The current study is being conducted to evaluate the relative bioavailability and single-
and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy
- 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]).
- 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
- 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
- The subject has used tobacco (or nicotine products) during the 6 months prior to
- The subject has participated in an investigational drug study within the 30 days
before receiving study drug