At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Correlation of Mesalamine Pharmacokinetics With Local Availability
In Brief
A clinical study evaluating Pentasa 500 mg capsule x 2 with 240 mL water; single dose, Apriso 375 mg capsule x 3 with 240 mL water; single dose, and 2 other interventions for Local Drug Concentration in Gastrointestinal Tract. Completed, enrolled 30 participants across 1 site.
Detailed 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.