Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
BASi Clinical Research Unit
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01380457
First received: June 16, 2011
Last updated: June 22, 2011
Last verified: June 2011

June 16, 2011
June 22, 2011
January 2006
April 2006   (final data collection date for primary outcome measure)
Bioequivalence [ Designated as safety issue: No ]
To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.
Same as current
Complete list of historical versions of study NCT01380457 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions
A Comparative Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
To Determine Bioequivalence Under Fasting Conditions
  • Drug: Dronabinol
    Capsules, 10 mg, single dose, fasting conditions
    Other Name: Marinol
  • Drug: Marinol
    Capsules, 10 mg, single-dose, fasting conditions
    Other Name: Dronabinol
  • Experimental: A
    Subjects received the test formulated product manufactured by Pharmaceutics International, Inc. and marketed by Par Pharmaceutical, Inc. under fasting conditions
    Intervention: Drug: Dronabinol
  • Active Comparator: B
    Subjects received the reference listed drug manufactured by Banner Pharmacaps, Inc. and marketed by Unimed Pharmaceutical, Inc.
    Intervention: Drug: Marinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01380457
11885
No
Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
Par Pharmaceutical, Inc.
BASi Clinical Research Unit
Principal Investigator: Dilip K Guha-Ray, M.D. BASi Baltimore Clinical Research Unit
Par Pharmaceutical, Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP