Status:
COMPLETED
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multipl...
Detailed Description
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multipl...
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
- Intolerance or food allergy to Seville orange juice
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00960193
Start Date
February 1 2009
End Date
April 1 2009
Last Update
June 8 2011
Active Locations (1)
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1
PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota, United States, 58104