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NCT01999400 · ClinicalTrials.gov registry record · NA
Correlation of Mesalamine Pharmacokinetics With Local Availability
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT01999400: Completed NA study, sponsored by University of Michigan.
NCT01999400 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999400, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM\*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of p
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-04 |
| Est. Completion | 2017-04 |
| Phase | NA |
What the finished NCT01999400 record still lists
NCT01999400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Pentasa 500 mg capsule x 2 with 240 mL water; single dose is the first listed.
NCT01999400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999400 about?
NCT01999400 is a clinical study titled "Correlation of Mesalamine Pharmacokinetics With Local Availability". 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 trac...
What is the current status of trial NCT01999400?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2012-04. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01999400?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT01999400?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01999400's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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