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NCT00751699 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
A Phase 1 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT00751699 is a Phase 1 study that has completed, run by Warner Chilcott. The registered enrollment target is 37 participants.
The verdict
NCT00751699, a Phase 1 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e \[%\]) over the 24-hour period on Day 7.
Interventions
- DRUG Asacol
- DRUG Lialda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00751699
The ClinicalTrials.gov registry entry for NCT00751699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Asacol is the first listed.
NCT00751699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00751699 about?
NCT00751699 is a clinical study titled "Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers". This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concent...
What is the current status of trial NCT00751699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2007-03. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00751699?
The interventions under investigation include: Asacol (DRUG), Lialda (DRUG).
Who is sponsoring clinical trial NCT00751699?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
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