Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011063
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-02-09
Brief Title:
Effect of Ginkgo Biloba on Phenytoin Elimination
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Effect of Ginkgo Biloba on Phenytoin Pharmacokinetics
Status:
COMPLETED
Status Verified Date:
2001-01
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:
This study will examine how the herbal remedy ginkgo biloba may affect the bodys elimination of other medicines Many people take ginkgo biloba to improve memory mental alertness and overall feeling of well being Since this product is considered a food supplement and not a drug it is not subject to the rigorous pre-market testing required for prescription and over-the-counter OTC drugs As a result information has not been collected on possible interactions between ginkgo biloba and other medications This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures
Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study Candidates will provide a medical history and undergo a physical examination and routine blood tests Women of childbearing age must use a reliable form of birth control other than oral contraceptives the pill
For at least 2 weeks before the study and throughout its duration study participants may not have any of the following 1 medications that can affect platelet function eg aspirin Motrin Advil Nuprin ibuprofen etc 2 alcoholic beverages 3 grapefruit and grapefruit juice and 4 all medications except those given by study personnel
On day 1 of the study subjects take one 500-mg dose of phenytoin at 800 AM On an empty stomach Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose Blood samples are drawn just before dosing and again at 05 1 15 2 4 6 8 10 12 24 32 48 72 and 96 hours after the dose Blood drawn on this first study day is collected through a catheter small plastic tube placed in a vein to avoid multiple needlesticks After the 12-hour sample is collected the subject goes home and then returns to the clinic for the remaining blood draws which are taken by direct needlestick
When the blood sampling is completed subjects begin ginkgo therapy The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day at 8 AM and 8 PM for 4 weeks At the end of the 4 weeks subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure Subjects continue taking ginkgo during this second phenytoin study
Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study Candidates will provide a medical history and undergo a physical examination and routine blood tests Women of childbearing age must use a reliable form of birth control other than oral contraceptives the pill
For at least 2 weeks before the study and throughout its duration study participants may not have any of the following 1 medications that can affect platelet function eg aspirin Motrin Advil Nuprin ibuprofen etc 2 alcoholic beverages 3 grapefruit and grapefruit juice and 4 all medications except those given by study personnel
On day 1 of the study subjects take one 500-mg dose of phenytoin at 800 AM On an empty stomach Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose Blood samples are drawn just before dosing and again at 05 1 15 2 4 6 8 10 12 24 32 48 72 and 96 hours after the dose Blood drawn on this first study day is collected through a catheter small plastic tube placed in a vein to avoid multiple needlesticks After the 12-hour sample is collected the subject goes home and then returns to the clinic for the remaining blood draws which are taken by direct needlestick
When the blood sampling is completed subjects begin ginkgo therapy The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day at 8 AM and 8 PM for 4 weeks At the end of the 4 weeks subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure Subjects continue taking ginkgo during this second phenytoin study
Detailed Description:
Gingko biloba is a complementary or alternative medication used for purported cognitive enhancing effects Despite its widespread use there is limited data regarding potential for drug interactions The purpose of this study is to determine the effect of administration of ginkgo for 4 weeks on single dose phenytoin pharmacokinetics Eight healthy volunteers will take a single 500mg dose of phenytoin capsules orally with serial blood samples collected over 96 hours for determination of phenytoin pharmacokinetics Following the pharmacokinetic study subjects will begin taking 2 60mg capsules 120mg total of ginkgo twice daily for 28 days Following 28 days of ginkgo subjects will then again undergo phenytoin pharmacokinetic evaluations with blood samples obtained over 96 hours for determination of phenytoin pharmacokinetics The ratio of geometric means for phenytoin pharmacokinetic parameter values and 90 confidence intervals about the ratio of log transformed parameter values will be calculated Confidence intervals falling within the 80-125 range will characterize the pharmacokinetic parameter values before and after ginkgo to be equivalent
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 |
|---|---|---|---|
| 01-CC-0080 | None | None | None |