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NCT00960323 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study Between Colchicine and Atorvastatin
A Phase 1 study, sponsored by Mutual Pharmaceutical Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00960323 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants.
The verdict
NCT00960323, 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 cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses of atorvastatin 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 Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00960323
The ClinicalTrials.gov registry entry for NCT00960323 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.
NCT00960323 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00960323 about?
NCT00960323 is a clinical study titled "Drug-Drug Interaction Study Between Colchicine and Atorvastatin". Colchicine is a substrate for cytochrome P450 3A4 (CYP3A4). In-vitro studies have indicated that the ortho-and para-hydroxylated metabolites of atorvastatin may be CYP3A4/5 competitive and mechanism-based inhibitors (MBI). This study will evaluate the effect of multiple doses of atorvastatin on the ...
What is the current status of trial NCT00960323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-02. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00960323?
The interventions under investigation include: Colchicine (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT00960323?
This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.
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