Clinical trial NCT01380457: Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Official title: A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fasting Conditions
Keywords: bioequivalence
dronabinol
fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BASi Clinical Research Unit
First posted: 2011-06-27
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Detailed description: To compare the plasma levels of dronabinol (delta-9-tetrahydrocannabinol)and the principle active metabolite 11-OH-delta-9-tetrahydrocannabinol levels produced after administration of the test formulation with those produced after administration of a marketed reference product, under fasted conditions.

Eligibility 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

Primary outcomes:
measure: Bioequivalence
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: BASi
state: Maryland
Study officials:
affiliation: BASi Baltimore Clinical Research Unit
name: Dilip K Guha-Ray, M.D.
role: PRINCIPAL_INVESTIGATOR
References: