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Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01380457
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
BASi Clinical Research Unit
Information provided by:
Par Pharmaceutical, Inc.

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

Condition or disease Intervention/treatment Phase
To Determine Bioequivalence Under Fasting Conditions Drug: Dronabinol Drug: Marinol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
Study Start Date : January 2006
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: A
Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions
Drug: Dronabinol
Capsules, 10 mg, single dose, fasting conditions
Other Name: Marinol

Active Comparator: B
Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.
Drug: Marinol
Capsules, 10 mg, single-dose, fasting conditions
Other Name: Dronabinol

Primary Outcome Measures :
  1. Bioequivalence
    To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01380457

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United States, Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Par Pharmaceutical, Inc.
BASi Clinical Research Unit
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Principal Investigator: Dilip K Guha-Ray, M.D. BASi Baltimore Clinical Research Unit

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Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc. Identifier: NCT01380457    
Other Study ID Numbers: 11885
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011
Keywords provided by Par Pharmaceutical, Inc.:
Additional relevant MeSH terms:
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Pathologic Processes
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists