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NCT00983242 · ClinicalTrials.gov registry record · Phase 1

Drug-Drug Interaction Between Colchicine and Verapamil ER

A Phase 1 study, sponsored by Mutual Pharmaceutical Company.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00983242 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

NCT00983242, 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). Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp. This study will evaluate the effect of multiple doses of extended-release verapamil hydrochloride (verapamil HCl ER) 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 Verapamil HCl ER

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-09
Est. Completion 2008-10
Phase Phase 1

Sponsor

Mutual Pharmaceutical Company

27 total trials

What the Registry Record Tells You About NCT00983242

The ClinicalTrials.gov registry entry for NCT00983242 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.

NCT00983242 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00983242 about?

NCT00983242 is a clinical study titled "Drug-Drug Interaction Between Colchicine and Verapamil ER". Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp. This study will evaluate the effect of multiple doses of extended-release verapamil hydrochloride (verapamil HCl ER) on the ...

What is the current status of trial NCT00983242?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-09. Estimated completion is 2008-10.

What interventions are being tested in trial NCT00983242?

The interventions under investigation include: Colchicine (DRUG), Verapamil HCl ER (DRUG).

Who is sponsoring clinical trial NCT00983242?

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.