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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 plasma

concentration 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

Page last updated: August 23, 2015

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