Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
This is a comparative study to assess bioavailability of a proposed alternate dosage form
 against the current FDA-approved branded product.
Inclusion Criteria:

 1. Male and female healthy subjects between 18 and 55 years of age, inclusive.

 2. Subjects must have a body mass index (BMI) within 19 and 29.9 kg/m2, inclusive and
 weigh a minimum of 50 kg (110 pounds).

 3. Subjects must be in general good health as determined by medical history, physical
 examination, or laboratory evaluations conducted at the screening visit and upon
 admission to the clinic. Examination should include a thorough examination of oral
 cavity for any abnormal findings.

 4. Subjects must be non-smokers, defined as not having used any tobacco products in the
 past six months. Negative results from a urine cotinine test conducted at Screening.

 5. Subjects must be able to provide informed consent after risks and benefits have been
 explained, and be willing to comply with study procedures.

 6. Female subjects of childbearing potential must not be pregnant or nursing; and must be
 surgically sterile; one year postmenopausal; or on hormonal contraceptive agent(s),
 diaphragm or condom with spermicidal foam or jelly, or IUD for at least three months
 prior to drug administration and agree to use the same method of contraception for at
 least one month after the last drug administration.

 7. Negative urine pregnancy test at screening and prior to drug administration of each
 period.

 8. Negative HIV 1, hepatitis C virus (HCV) antibody, hepatitis B surface antigen within
 30 days prior to the start of the study.

 9. Negative results from screening for drugs of abuse at Screening and Day-1 (check-in)
 prior to drug administration during all study periods.

 Exclusion Criteria:

 1. Known hypersensitivity or allergy to dronabinol, Marinol, marijuana, hashish, or
 sesame oil.

 2. Have participated in an investigational trial within 30 days or six half-lives of the
 test drug's biologic activity, whichever is longer, before the time of first study
 dose in this study.

 3. Presence of visible signs of an infection, mucositis, cold sores, lesions, local
 irritation, periodontal disease of the oral cavity or any abnormal finding in the oral
 cavity. In addition, evidence of piercings of the tongue, lip, or anywhere in the oral
 cavity or a history of oral cavity piercings.

 4. Have donated or received blood or blood products within 30 days prior to the first
 study dose.

 5. Have received any prescription drug (excluding hormonal contraceptives) within 14 days
 of study drug administration, over-the-counter drugs within seven days of study drug
 administration, and/or vitamins or herbal supplements within three days of study drug
 administration.

 6. Significant bradycardia or tachycardia defined as having a resting heart rate <45 bpm
 or >100 bpm, respectively.

 7. Clinical evidence of either hypotension (defined as systolic blood pressure <90 mmHg
 or diastolic blood pressure <50 mmHg), or hypertension (defined as systolic blood
 pressure >139 mmHg or diastolic blood pressure >89 mmHg).

 8. Any history of clinically significant organ system (cardiovascular, neurological,
 hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders or
 ongoing infectious diseases; or any other conditions that might interfere with the
 absorption, distribution, metabolism or excretion of the study drug, or that would
 place the subject at increased risk.

 9. Use of marijuana (directly or indirectly) within 90 days prior to drug administration
 and during the course of the study.

 10. History of treatment for alcohol abuse, significant mental illness, physical
 dependence to any opioid, barbiturates, amphetamines, cocaine, or benzodiazepines in
 the past 10 years.