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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014