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NCT00840203 · ClinicalTrials.gov registry record · Phase 1
Mesalamine 4 gm/60 mL Rectal Enema
A Phase 1 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00840203: Completed Phase 1 study, sponsored by Teva Pharmaceuticals USA.
NCT00840203 is a Phase 1 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00840203, a Phase 1 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Rowasa® 4 gm/60 mL Rectal Enema
- DRUG Mesalamine 4 gm/60 mL Rectal Enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2003-05 |
| Est. Completion | 2003-06 |
| Phase | Phase 1 |
What the finished NCT00840203 record still lists
NCT00840203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Rowasa® 4 gm/60 mL Rectal Enema is the first listed.
NCT00840203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00840203 about?
NCT00840203 is a clinical study titled "Mesalamine 4 gm/60 mL Rectal Enema". The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.
What is the current status of trial NCT00840203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2003-05. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00840203?
The interventions under investigation include: Rowasa® 4 gm/60 mL Rectal Enema (DRUG), Mesalamine 4 gm/60 mL Rectal Enema (DRUG).
Who is sponsoring clinical trial NCT00840203?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00840203's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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