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NCT00318201 · ClinicalTrials.gov registry record · Phase 4
The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers
A Phase 4 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT00318201: Completed Phase 4 study, sponsored by Indiana University.
NCT00318201 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00318201, a Phase 4 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study Summary
We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these medications are metabolized. Hypothesis: We will test the hypothesis that the extent of drug-drug interaction caused by the combination of erythromycin and diltiazem is not predictable from the extent of interaction produced by each inhibitor alone. Specifically we will test the hypothesis that the combination of erythromycin and diltiazem will cause a greater decrease in midazolam intravenous and oral clearance than the sum of the decreases caused by each inhibitor alone.
Interventions
- DRUG Erythromycin
- DRUG Diltiazem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00318201 record still lists
NCT00318201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Erythromycin is the first listed.
NCT00318201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00318201 about?
NCT00318201 is a clinical study titled "The Effect of Concomitant Administration of Erythromycin and Diltiazem on CYP3A Activity in Healthy Volunteers". We, the researchers at the Indiana University School of Medicine, are doing this study to better understand how the effects of certain medications are altered when taken simultaneously, or in combination with each other. We will also look at how each volunteer's genes (DNA) may affect the way these ...
What is the current status of trial NCT00318201?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2006-04. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00318201?
The interventions under investigation include: Erythromycin (DRUG), Diltiazem (DRUG).
Who is sponsoring clinical trial NCT00318201?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00318201's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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