Drug Interactions and Bioavailability of Cranberry
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|ClinicalTrials.gov Identifier: NCT00200759|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Healthy Drug Interactions||Drug: Cranberry juice and capsules||Phase 1|
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 or chronic conditions. Cytochromes P450 enzymes are a group of proteins involved in metabolism of certain substances. A group of cytochrome P-450 (CYP) enzymes are extensively involved in drug metabolism. The pharmacokinetics of many drugs often vary considerably among individuals, largely because of variations in the expression of different cytochrome P-450 (CYP) enzymes in the liver and other tissues. Flavonoids are antioxidants that may have health benefits. The flavonoids may also be responsible for cranberry's effects on urinary tract infections.
To evaluate the drug interaction potential of cranberry, single doses of the three safe probe drugs alprazolam, dextromethorphan, and caffeine will be administered before and after a 14-day treatment period with cranberry powder. Changes in the pharmacokinetics of these probe drugs will indicate the degree of enzyme inhibition or induction. The key pharmacokinetic parameters for four major CB flavonoids will be estimated by following the plasma concentration versus time course of absorbed flavonoids and their excretion in urine. The area under the plasma concentration versus time curve (AUC), oral clearance (Clo), terminal elimination half-life (T1/2) and renal clearance (Clren) will be determined for: epicatechin, quercetin (total glycosides), procyanidin A2, and cyanidin-3-galactoside.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Drug Interactions and Bioavailability of Cranberry|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200759
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Jennifer L Donovan, PhD||Medical University of South Carolina|