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Correlation of Mesalamine Pharmacokinetics With Local Availability

NCT01999400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-15

Study results available
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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.

Conditions

  • Local Drug Concentration in Gastrointestinal Tract

Interventions

DRUG

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

Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose

Sponsors & Collaborators

Principal Investigators

  • Duxin Sun, Ph.D. · University of Michigan, College of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-09-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999400 on ClinicalTrials.gov