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NCT00983515 · ClinicalTrials.gov registry record · Phase 1

Drug-Drug Interaction Between Colchicine and Ritonavir

A Phase 1 study, sponsored by Mutual Pharmaceutical Company.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00983515 is a Phase 1 study that has completed, run by Mutual Pharmaceutical Company. The registered enrollment target is 24 participants.

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The verdict

NCT00983515, a Phase 1 study, has completed, sponsored by Mutual Pharmaceutical Company.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir 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 Ritonavir

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-07
Est. Completion 2008-08
Phase Phase 1

Sponsor

Mutual Pharmaceutical Company

27 total trials

What the Registry Record Tells You About NCT00983515

The ClinicalTrials.gov registry entry for NCT00983515 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.

NCT00983515 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00983515 about?

NCT00983515 is a clinical study titled "Drug-Drug Interaction Between Colchicine and Ritonavir". Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tol...

What is the current status of trial NCT00983515?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-07. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00983515?

The interventions under investigation include: Colchicine (DRUG), Ritonavir (DRUG).

Who is sponsoring clinical trial NCT00983515?

This trial is sponsored by Mutual Pharmaceutical Company, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.