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.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: mesalamine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Single- And Multiple-Dose, Relative Bioavailability and Pharmacokinetic Study of Encapsulated Mesalamine Granules Administered Orally to Healthy Volunteers
Study Start Date : February 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: mesalamine
encapsulated mesalamine granules

Primary Outcome Measures :
  1. Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622375

United States, Texas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Audrey Shaw, PhD Valeant Pharmaceuticals International, Inc.

Responsible Party: Salix Pharmaceuticals Identifier: NCT00622375     History of Changes
Other Study ID Numbers: MPPK1003
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Pharmacokinetic study
Healthy subjects

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents