Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200759
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2005-09-12
Brief Title:
Drug Interactions and Bioavailability of Cranberry
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Drug Interactions and Bioavailability of Cranberry
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 blood and in the urine
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 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 cranberrys 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 T12 and renal clearance Clren will be determined for epicatechin quercetin total glycosides procyanidin A2 and cyanidin-3-galactoside
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 T12 and renal clearance Clren will be determined for epicatechin quercetin total glycosides procyanidin A2 and cyanidin-3-galactoside
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002073-01 | NIH | None | httpsreporternihgovquickSearchR21AT002073-01 |