bioavailability study of dronabinol capsules 10 mg under fasting conditions

Conditions: To Determine Bioequivalence Under Fasting Conditions

Summary: the purpose of this study is to compare the rate and extent of absorption of dronabinol 10 mg capsules verses marinol.

to compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-oh-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.

Eligibility criteria:
inclusion criteria: * healthy volunteers, 18 - 55 years of age * subjects must be within 18 to 29.9 kilograms/m2 per the bmi * general good health as determined by medical history and physical examination within 30 days prior to the start of the study * blood chemistry, hematology, and urinalysis tests will be performed within 30 days prior to the start of the study * no participation in an investigational drug study or donation of blood within 30 days prior to the start of the study * at screening, subjects must have blood pressure and pulse rate within specified ranges * no grapefruit juice or grapefruit-containing products for at least 72 hours prior to drug administration, each period. subjects will be queried at check-in each period on consumption of grapefruit juice or grapefruit containing products. results will be recorded and reported in the final report. * no alcohol consumption for at least 24 hours prior to drug administration, each period * no caffeine or xanthine consumption for 48 hours prior prior to drug administration, each period * no prescription drugs (excluding hormonal contraceptives) within 14 days prior to drug administration, each period * subjects should refrain from taking otc preparations, and/or nutritional supplements within 7 days prior to drug administration, each period. subjects shall refrain from taking herbal remedies within 14 day prior to drug administration, and throughout the study periods * female subjects must not be pregnant or nursing; and must be surgically sterile; one year post-menopausal; or on hormonal contraceptive agents), a diaphragm or condom with spermicidal foam or jelly, or iud for at least 3 months prior to drug administration and agree to use the same method of contraception for at least 1 month after the last drug administration * negative serum pregnancy test at screening and negative urine pregnancy test prior to drug administration, each period * negative hiv 1, hepatitis b surface antigen, an urine screen for drugs of abuse within 30 days prior to the start of the study exclusion criteria: * disease or condition that could impact interpretation of study results or a condition which treatment would be contraindicated per currently approved product labeling * subjects had any of the following conditions: * used any prescription or otc medication within 14 days of study initiation * a positive urine test for illicit drugs * participated in a clinical investigation within the past 30 days * had clinically significant allergies to drugs or foods, ot * any condition that might place them at increased risk of complications

Keywords: bioequivalence dronabinol fasting