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NCT01418365 · ClinicalTrials.gov registry record · Phase 1
Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
A Phase 1 study of Healthy, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01418365: Completed Phase 1 study of Healthy, sponsored by Shire.
NCT01418365 is a Phase 1 study of Healthy that has completed, run by Shire. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01418365, a Phase 1 study of Healthy, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine
Primary Outcome
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Conditions Studied
Interventions
- DRUG Metronidazole + MMX Mesalazine/mesalamine placebo
- DRUG Metronidazole + MMX Mesalazine/mesalamine
Study Locations (1)
Kansas
- PRA International - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-08-22 |
| Est. Completion | 2011-10-05 |
| Phase | Phase 1 |
What the finished NCT01418365 record still lists
NCT01418365 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 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Metronidazole + MMX Mesalazine/mesalamine placebo is the first listed.
NCT01418365 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01418365 about?
NCT01418365 is a clinical study titled "Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine". Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine
What is the current status of trial NCT01418365?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-08-22. Estimated completion is 2011-10-05.
What conditions does trial NCT01418365 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01418365?
The interventions under investigation include: Metronidazole + MMX Mesalazine/mesalamine placebo (DRUG), Metronidazole + MMX Mesalazine/mesalamine (DRUG).
Who is sponsoring clinical trial NCT01418365?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01418365 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01418365's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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