| COLD CAPSULE IV
COLD CAPSULE V
COMPOUND 65
SOMA COMPOUND
|
OTC |
NCT00009542 ↗ |
Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan |
Completed |
National Institutes of Health Clinical Center (CC) |
Phase 4 |
2001-01-01 |
This study will examine how kava-a widely used herbal remedy-may affect the body's
elimination of other medicines. Many people take kava to reduce anxiety or cause sedation.
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 kava and other
medications. This study will look at how kava affects the elimination of caffeine-a compound
commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough
suppressant.
Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study.
Candidates will provide a medical history and undergo a physical examination and routine
blood tests. Women of childbearing age will have a urine pregnancy test.
Study participants will not drink alcoholic beverages or take any medications (except those
given in the study) for 2 weeks prior to the study and throughout its duration. In addition,
they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at
least 72 hours before and throughout each study day that urine is collected.
On day 1 of the study, study subjects will take one dose each of caffeine and
dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then
collect all their urine after the dosing for the rest of the day and including the next
mornings first urine. They will bring the urine samples to the Clinical Center when the
collection is complete. This procedure will be repeated 1 week later (study day 8). After the
second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day
for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the
dextromethorphan and caffeine dosing and urine collection described above, while continuing
to take kava.
Subjects will have an electroencephalograph (EEG) done before starting kava and again at the
end of kava (study day 30). For this procedure, several electrodes (metal cups attached to
wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space
between the electrode and the scalp to ensure good contact. The electrodes will remain in
place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG
recording.
Participation in the study will end with another physical examination and blood tests
following the second EEG and urine collection.
|
| ASPIRIN
IBUPROFEN
MEPRO-ASPIRIN
MOTRIN
MOTRIN IB
NUPRIN
PHENYTOIN
|
OTC |
NCT00011063 ↗ |
Effect of Ginkgo Biloba on Phenytoin Elimination |
Completed |
National Institutes of Health Clinical Center (CC) |
Phase 1 |
2001-02-01 |
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.
|
| CRIXIVAN |
OTC |
NCT00011635 ↗ |
The Effect of Milk Thistle on the Pharmacokinetics of Indinavir |
Completed |
National Institutes of Health Clinical Center (CC) |
Phase 1 |
2001-02-01 |
Complementary and alternative medicines are widely used in the HIV-infected population.
Recent data have shown serious drug interactions between certain complementary medicines and
protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in
HIV-infected patients for treatment of hepatitis or as a hepato-protectant. Data are
available suggesting that it may alter cytochrome P4503A4-mediated drug metabolism. To
evaluate the effect of milk thistle on the protease inhibitor, indinavir (IDV), ten healthy
subjects will receive IDV (Crixivan) alone and in combination with an over-the-counter
silymarin preparation. IDV will initially be administered alone at a dose of 800 mg Q8H for
four doses and serial samples will be collected for determination of IDV pharmacokinetics
after the morning dose on day 2. Subjects will then initiate therapy will milk thistle using
a standardized formulation and dose for three weeks after which subjects will then again take
4 doses of IDV and have serial samples collected for IDV plasma concentrations. There will
then be a 11-day washout period with no drugs, after which IDV will again be given for 4
doses and samples will be collected evaluate the offset of the effects of milk thistle. To
examine the effect of milk thistle on other CYP450 pathways, subjects will receive a single
dose of caffeine and dextromethorphan and have urine collected before and after milk thistle,
and after the washout period. Indinavir, caffeine, and dextromethorphan concentrations in
plasma or urine will be determined using validated HPLC methods. Steady-state
noncompartmental parameters of indinavir in the presence and absence of milk thistle will be
determined. Pharmacokinetic parameters will be compared using ANOVA that will include factors
for a period effect and a treatment effect. Statistical analyses will include calculation of
the mean ratio of the AUC in the treatment phases compared to IDV alone and determination of
95% confidence intervals. This study will help define the drug interaction potential of
complementary and alternative therapies in HIV-infected patients.
|
| ANTITUSSIVE
LORAZEPAM
VALIUM
|
OTC |
NCT00055549 ↗ |
Dextromethorphan to Treat Patients With Voice Spasms |
Completed |
National Institute of Neurological Disorders and Stroke (NINDS) |
Phase 1 |
2003-03-04 |
This study will examine how dextromethorphan, a drug that alters reflexes of the larynx
(voice box), might change voice symptoms in people with voice disorders due to uncontrolled
laryngeal muscle spasms. These include abductor spasmodic dysphonia (breathy voice breaks),
adductor spasmodic dysphonia (vowel breaks), muscular tension dysphonia (tight strained
voice), and vocal tremor (tremulous voice). Dextromethorphan-one of a group of drugs called
NMDA antagonists-has been used for years in over-the-counter cough suppressant medicines. In
animal studies, the drug has blocked one of the reflexes in the larynx that may be associated
with spasms in the laryngeal muscles. This study will compare the effects of
dextromethorphan, lorazepam (a valium-type drug), and a placebo (inactive substance) in
patients with the four types of voice disorders described above.
Patients with spasmodic dysphonia, muscular tension dysphonia and vocal tremor may be
eligible for this study. Individuals who smoke or use tobacco, who have vocal nodules or
polyps, or who have a history of airway obstruction may not participate. Candidates will be
screened with a medical history and physical examination, a questionnaire, voice recording
(repeating sentences into a microphone), and nasolaryngoscopy (examination of the larynx with
a tube advanced through the nose). For the nasolaryngoscopy, the inside of the nose is
sprayed with a decongestant (to open the nasal passages) and possibly a local anesthetic. A
small, flexible tube called a nasolaryngoscope is passed through the nose to look at the
larynx during speech and other tasks, such as singing, whistling and prolonged vowels.
Participants will be admitted to the NIH Clinical Center for each of three visits, which will
last from the afternoon of one day to late afternoon of the following day. At each visit,
patients will complete a questionnaire, baseline speech recording, and a test for sedation
level. They will take three pills-either dextromethorphan, lorazepam, or placebo-one every 6
hours. Vital signs will be checked every 6 hours and the level of sedation during waking
hours will be monitored. One to three hours after taking the third pill, speech recording,
questionnaire and test of sedation will be repeated to check for possible voice changes.
Patients will be given a different pill at each visit.
...
|
| LOVASTATIN |
OTC |
NCT00092846 ↗ |
A 6-Month Consumer Behavior Study of a Self-Management System (0803-084)(COMPLETED) |
Completed |
Merck Sharp & Dohme Corp. |
Phase 3 |
2002-12-04 |
The purpose of this study is to evaluate the ability of patients with intermediate risk of
heart disease to appropriately use a Self-Management System.
|
