Correlation of Mesalamine Pharmacokinetics With Local Availability
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Local Drug Concentration in Gastrointestinal Tract
Intervention: Pentasa 500 mg capsule x 2 with 240 mL water; single dose (Drug); Apriso 375 mg capsule x 3 with 240 mL water; single dose (Drug); Lialda 1200 mg tablet x 1 with 240 mL water; single dose (Drug); Asacol 400 mg tablet x 1 with 240 mL water; single dose (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Michigan Official(s) and/or principal investigator(s): Duxin Sun, Ph.D., Principal Investigator, Affiliation: University of Michigan, College of Pharmacy
Summary
This study is designed to provide data to the FDA correlating pharmacokinetics with local
availability of medications within the gastrointestinal tract. This study will support the
establishment of scientifically based standards for evaluating drugs which act locally
within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify
how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel
disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve
the physiologically based models for drug absorption from the intestine. Information from
this study in concert with in vitro dissolution data will be used to evaluate in vivo-in
vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution
of mesalamine products.
Clinical Details
Official title: Correlation of Mesalamine Pharmacokinetics With Local Availability
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: concentration of mesalamine and metabolite (N-acetyl-mesalamine) in plasmaconcentration of mesalamine and metabolite (N-acetyl-mesalamine) in urine concentration of mesalamine and metabolite (N-acetyl-mesalamine) in feces concentration of mesalamine and metabolite (N-acetyl-mesalamine) in gastrointestinal fluid pH of gastrointestinal fluid
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria
1. Adults age 18 to 55.
2. Male or female voluntarily able to give informed consent.
3. Body mass index (BMI) 18. 5 to 35.
Exclusion Criteria
1. Adults unable to consent for themselves or mentally incapacitated.
2. Prisoners.
3. Significant clinical illness within 3 weeks prior to Screening.
4. Use of concomitant medications within 2 weeks prior to receiving study drug,
including but not limited to prescription drugs, herbal and dietary supplements, over
the counter medications, and vitamins. Oral contraception is permitted.
5. History of gastrointestinal surgery.
6. History of allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the
ingredients of Asacol, Pentasa, Apriso, or Lialda.
7. History of severe allergic diseases including drug allergies, with the exception of
seasonal allergies.
8. Any other factor, condition, or disease, including, but not limited to,
cardiovascular, renal, hepatic, or gastrointestinal disorders that may, in the
opinion of the Investigator, jeopardize the safety of the patient or impact the
validity of the study results.
9. History of drug addiction or alcohol abuse within the past 12 months.
10. Pregnant or lactating females.
11. Surgery within the past 3 months.
12. Received an investigational drug within 60 days prior to receiving the study drug.
13. Any clinically significant abnormal lab values during Screening.
Locations and Contacts
University of Michigan, Ann Arbor, Michigan 48109, United States
Additional Information
Related publications: Lionberger RA. FDA critical path initiatives: opportunities for generic drug development. AAPS J. 2008;10(1):103-9. doi: 10.1208/s12248-008-9010-2. Epub 2008 Feb 20. Review.
Starting date: April 2012
Last updated: August 11, 2015
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