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.

Study Overview

• Status: Completed
• Conditions: To Determine Bioequivalence Under Fasting Conditions
• Intervention / Treatment: Drug: Dronabinol; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • BASi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Dronabinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Bioequivalence	To conclude bioequivalence; 90% geometric confidence interval was contained within the limits 0.8 to 1.25.

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: BASi Clinical Research Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): April 1, 2006
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: bioequivalence; dronabinol; fasting
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 11885 (Other Grant/Funding Number: DAIDS Protocol Number)