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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 is a Phase 4 study that has completed, run by Indiana University. The registered enrollment target is 7 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00318201
The ClinicalTrials.gov registry entry for NCT00318201 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Erythromycin is the first listed.
NCT00318201 reports 0 study locations.
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.
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