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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: Completed Phase 1 study, sponsored by Warner Chilcott.
NCT00751699 is a Phase 1 study that has completed, run by Warner Chilcott. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00751699 record still lists
NCT00751699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Asacol is the first listed.
NCT00751699 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00751699's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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