PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622375

MPPK1003

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: mesalamine