PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Mesalamine

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