Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: BASi Clinical Research Unit
• Treatments: Dronabinol

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