Status:
COMPLETED
PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00622375
Start Date
February 1 2008
End Date
May 1 2008
Last Update
November 18 2019
Active Locations (1)
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1
Dallas, Texas, United States, 75247