Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bausch Health Americas, Inc.
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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/\[height\]).
You may not be if
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
Clareo Health | PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
