Expired Study
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Baltimore, Maryland 21201


Purpose:

The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.


Study summary:

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.


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


NCT ID:

NCT01380457


Primary Contact:

Principal Investigator
Dilip K Guha-Ray, M.D.
BASi Baltimore Clinical Research Unit


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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