PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622375
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : December 23, 2009
Information provided by:
Valeant Pharmaceuticals International, Inc.

February 14, 2008
February 25, 2008
December 23, 2009
February 2008
February 2008   (Final data collection date for primary outcome measure)
Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics
Same as current
Complete list of historical versions of study NCT00622375 on Archive Site
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PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers
A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers
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.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Drug: mesalamine
encapsulated mesalamine granules
Experimental: 1
Intervention: Drug: mesalamine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Salix Pharmaceuticals
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Audrey Shaw, PhD Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP