Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies.

Not Recruiting

Trial ID: NCT00304434


Objective 1: Determine the safety and toxicity profile of Tamiflu administered in combination with probenecid in healthy adults.Objective 2: Determine the pharmacokinetic profile of Tamiflu and probenecid in healthy adults.

Official Title

Oseltamivir (Tamiflu) Dosing Strategies for Use During Influenza Prophylaxis (VA01)

Stanford Investigator(s)


Inclusion Criteria:

Subjects will include males and non-pregnant females 18 years or older Subjects who can
understand the study and potential safety concerns and can sign the informed consent form
prior to admission to this study Subjects that are willing to complete all the required
assessments, tests and evaluations and able to make all study visits Hemoglobin > 10.0 g/dL
for males and > 9.0 g/dL for females; b) Platelet count of > 75,000 / L; c) Absolute
neutrophil count > 1000 / L; SGOT and SGPT < than 2.5 times normal upper limit (UL); Serum
uric acid WNL; Creatinine < 1.5 times normal upper limit (normal UL 1.5 mg/dL) for the < 65
years of age group and MUST be WNL for the > 65 years of age group; creatinine clearance >
50 mL/min

Exclusion Criteria:

Subjects with a creatinine clearance of < 50 mL/min Subjects who are pregnant or breast
feeding females Subjects who are not employing adequate contraception Subjects who are drug
or alcohol abusers and in the opinion of the investigator would interfere with subject
compliance and safety Subjects who are currently participating in any other clinical
research study Any acute serious infection requiring prescription therapy within 14 days
prior to Day 1 of the study Subjects who may have or recently been exposed to influenza
Subjects with gout, blood dyscrasias, or history of hypersensitivity to sulfonamide drugs
Subjects with contraindications to the study medications History of allergic reaction to
probenecid Have kidney disease, kidney stones, or poorly functioning kidneys Have active
peptic ulcer disease On high dose aspirin or salicylate therapy

Receiving any of the following medications (relative contraindication for probenecid):

Acyclovir, allopurinol, penicillamine, clofibrate, rifampin, methotrexate, zidovudine,
theophylline, dapsone, penicillins or cephalosporins, nonsteroidal anti-inflammatory drugs
(NSAIDS) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Oruvail,
Orudis KT), diclofenac (Cataflam, Voltaren), etodolac (Lodine), fenoprofen (Nalfon),
flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen),
oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), and
naproxen (Aleve, Anaprox, Naprosyn); a sulfa-based medication such as sulfamethoxazole
(Bactrim, Septra, Gantanol), sulfasalazine (Azulfidine), sulfinpyrazone (Anturane),
sulfisoxazole (Gantrisin), and others; an oral diabetes medicine such as glipizide
(Glucotrol), glyburide (Micronase, Diabeta, Glynase), tolbutamide (Orinase), or tolazamide
(Tolinase); a barbiturate such as phenobarbital (Luminal, Solfoton), amobarbital (Amytal),
secobarbital (Seconal), and others; or a benzodiazepine (used to treat anxiety and panic
disorders and to induce sleep) such as alprazolam (Xanax), diazepam (Valium), lorazepam
(Ativan), temazepam (Restoril), chlordiazepoxide (Librium), clonazepam (Klonopin),
clorazepate (Tranxene), oxazepam (Serax), estazolam (ProSom), flurazepam (Dalmane),
quazepam (Doral), or triazolam (Halcion).


drug: Oseltamivir

drug: Probenecid

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305