Correlation of Mesalamine Pharmacokinetics With Local Availability
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
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.