The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10
mg capsules verses Marinol.
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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