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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.
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