Status:
COMPLETED
Drug Interactions and Bioavailability of Cranberry
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Conditions:
Healthy
Drug Interactions
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the potential of cranberry juice to interact with conventional drugs. This study will also determine the the amount of cranberry flavonoids that appear in the ...
Detailed Description
The use of cranberry (CB) juice and powders, both alone and in combination with conventional medicine, has become more common for the treatment of urinary tract infections (UTIs) and and other acute o...
Eligibility Criteria
Inclusion
- Females must have a negative urine pregnancy test prior to enrollment and must be committed to using barrier methods of birth control throughout the study.
Exclusion
- Clinically significant diseases or abnormal laboratory values as assessed during the screening medical history, physical exam, and laboratory evaluations.
- A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurologic disease. The exclusion criteria also includes 1) positive urine pregnancy test 2) The use of oral contraceptives 3) The lack of use of acceptable barrier methods of birth control unless abstinent
- Use of any concomitant medication including herbal medications or a history of hypersensitivity to the medications used in the study
- History of sensitivity to CB juice or products
- Poor metabolizers of CYP2D6
- Active smoking or use of caffeine-containing beverages for 2 weeks prior to and during the study
- Inability to conform with dietary restrictions required for the study
- Drug or alcohol abuse (more than 3 drinks/day)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00200759
Start Date
October 1 2004
End Date
December 1 2007
Last Update
May 25 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425