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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 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01999400
The ClinicalTrials.gov registry entry for NCT01999400 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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