HealthyPhase 1NCT00011063
Effect of Ginkgo Biloba on Phenytoin Elimination
A Phase 1 study testing Ginkgo Biloba in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ginkgo Biloba
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Apr 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Male or female.
Healthy by medical history and physical exam.
Age greater than 21 years old.
No concurrent medications.
Non-smoker (for at least 6 months if prior history of smoking).
Laboratory values wihin the following guidelines: AST/SGOT less than or equal to 1.5 times the upper limit of normal; bilirubin less than or equal to the upper limit of normal; serum creatinine less than or equal to the upper limit of normal; hemoglobin greater than or equal to 10 g/dl; albumin NML.
Females of childbearing potential must be using a reliable form of birth control other than hormonal contraceptives.
No concomitant therapy with other inhibitors or inducers of cytochrome P-450 mediated drug metabolism within 30 days of study.
Must have the ability to remain free of chronic medications and alcohol for at least 2 weeks prior to and during the study.
No use of oral contraceptives (phenytoin, and potentially ginko, may induce the clearance of oral contraceptive lead to potential oral contraceptive failure).
Must have the ability and willingness to avoid analgesics with antiplatelet activity for at least 2 weeks prior to and during the study.
No presence of renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric, or respiratory disease or any other condition that may interfere with the interpretation of the study results or not be in the best interests of the subject in the opinion of the principal investigator.
No positive serum pregnancy test.
No presence of persistent diarrhea or malabsorption that would interfere with the patient's ability to adequately absorb drugs.
No drug or alcohol use that may impair safety or adherence.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Effect of Ginkgo Biloba on Phenytoin Pharmacokinetics
This study will examine how the herbal remedy ginkgo biloba may affect the body's 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").
Read more
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 (e.g., 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 8:00 A.M.. 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 0.5, 1, 1.5, 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 A.M. and 8 P.M..) 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ginkgo Biloba
- Keywords
- Anti-Epileptic, CYP2C9, Herbal, Interaction, Metabolism, Drug Interaction, Drug Metabolism, Ginko Biloba, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo BilobaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startFeb 2001
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011063
- Sponsor's protocol ID
- 010080
- Other IDs
- 01-CC-0080
- Status last verified
- Jan 2001
- First submitted
- 9 Feb 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
PubMed 9820257Israel D, Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy. 1997 Sep-Oct;17(5):970-84.
PubMed 9324185Elion RA, Cohen C. Complementary medicine and HIV infection. Prim Care. 1997 Dec;24(4):905-19. doi: 10.1016/s0095-4543(05)70316-x.
PubMed 9386262
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Ginkgo Biloba on Phenytoin Pharmacokinetics
- ClinicalTrials.gov ID
- NCT00011063
- Acronym / sponsor ID
- 010080
- Conditions
- Healthy
- Keywords
- Anti-Epileptic, CYP2C9, Herbal, Interaction, Metabolism, Drug Interaction, Drug Metabolism, Ginko Biloba
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Feb 2001
- Study completion
- Apr 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine how the herbal remedy ginkgo biloba may affect the body's 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 (e.g., 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 8:00 A.M.. 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 0.5, 1, 1.5, 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 A.M. and 8 P.M..) 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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo Biloba | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9820257Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998 Nov 11;280(18):1569-75. doi: 10.1001/jama.280.18.1569.
- Background: PubMed 9324185Israel D, Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy. 1997 Sep-Oct;17(5):970-84.
- Background: PubMed 9386262Elion RA, Cohen C. Complementary medicine and HIV infection. Prim Care. 1997 Dec;24(4):905-19. doi: 10.1016/s0095-4543(05)70316-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ginkgo Biloba in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00011063, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.