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PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00622375
First received: February 14, 2008
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: mesalamine
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Individual pharmacokinetic parameters for mesalamine and its metabolites will be summarized with descriptive statistics [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mesalamine
encapsulated mesalamine granules

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622375

Locations
United States, Texas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Audrey Shaw, PhD Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00622375     History of Changes
Other Study ID Numbers: MPPK1003
Study First Received: February 14, 2008
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Pharmacokinetic study
Healthy subjects

Additional relevant MeSH terms:
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013