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Status:

COMPLETED

Drug-Drug Interaction Study Between Colchicine and Atorvastatin

Lead Sponsor:

Mutual Pharmaceutical Company, Inc.

Conditions:

Healthy

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief 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-b...

Detailed Description

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-...

Eligibility Criteria

Inclusion

  • Healthy adults 18-45 years of age
  • Non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
  • Body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive
  • Hemoglobin greater than or equal to 11.5g/dL

Exclusion

  • Recent participation (within 28 days) in other research studies
  • Recent significant blood donation or plasma donation
  • Pregnant or lactating
  • Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
  • Recent (2-year) history or evidence of alcoholism or drug abuse
  • History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
  • Drug allergies to colchicine or atorvastatin or any other HMG-CoA reductase inhibitor agents (i.e. simvastatin, lovastatin, rosuvastatin, fluvastatin, and pravastatin)

Key Trial Info

Start Date :

February 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00960323

Start Date

February 1 2009

End Date

March 1 2009

Last Update

March 30 2010

Active Locations (1)

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PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, United States, 58104