To Determine Bioequivalence Under Fasting Conditions Clinical Trial
Official title:
A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Verified date | June 2011 |
Source | Par Pharmaceutical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to compare the rate and extent of absorption of Dronabinol 10 mg capsules verses Marinol.
Status | Completed |
Enrollment | 69 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | BASi | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Par Pharmaceutical, Inc. | BASi Clinical Research Unit |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioequivalence | To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25. | No |
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