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NCT00984061 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of Colchicine and Clarithromycin
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00984061 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants.
The verdict
NCT00984061, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhibition of CYP 3A4 and P-gp on the pharmacokinetics of colchicine. It will also evaluate the safety and tolerability of concurrent administration of clarithromycin and a single dose of colchicine.
Interventions
- DRUG clarithromycin
- DRUG colchicine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00984061
The ClinicalTrials.gov registry entry for NCT00984061 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mutual Pharmaceutical Company, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which clarithromycin is the first listed.
NCT00984061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00984061 about?
NCT00984061 is a clinical study titled "Drug-Drug Interaction Study of Colchicine and Clarithromycin". Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across membranes. This study will evaluate the effect of clarithromycin-related inhib...
What is the current status of trial NCT00984061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00984061?
The interventions under investigation include: clarithromycin (DRUG), colchicine (DRUG).
Who is sponsoring clinical trial NCT00984061?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
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