Healthy
Conditions
Keywords
Pharmacokinetic study, Healthy subjects
Brief summary
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.
Interventions
DRUGmesalamine
encapsulated mesalamine granules
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics | 14 days |
Countries
United States
Outcome results
None listed