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NCT00983931 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00983931 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants.
The verdict
NCT00983931, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the effect of single-dose cyclosporine on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period
Interventions
- DRUG Colchicine
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-08 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00983931
The ClinicalTrials.gov registry entry for NCT00983931 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 Colchicine is the first listed.
NCT00983931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00983931 about?
NCT00983931 is a clinical study titled "Drug-Drug Interaction Study Between Colchicine and Cyclosporine". Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the effect of single-dose cyclosporine on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary obj...
What is the current status of trial NCT00983931?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-08. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00983931?
The interventions under investigation include: Colchicine (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00983931?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
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