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A Bioavailability Study on Dronabinol

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ClinicalTrials.gov Identifier: NCT03098940
Recruitment Status : Unknown
Verified March 2017 by Axim Biotechnologies.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Axim Biotechnologies

Brief Summary:
This study is a two part study

Condition or disease Intervention/treatment Phase
THC Drug: Chewing Gum Phase 1

Detailed Description:
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Chewing gum
Chewing gum with various doses of dronabinol
Drug: Chewing Gum
During the study healthy subjects will receive single doses of the various strengths of dronabinol

Active Comparator: Capsule (Marinol)
Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol
Drug: Chewing Gum
During the study healthy subjects will receive single doses of the various strengths of dronabinol




Primary Outcome Measures :
  1. Bioequivalence [ Time Frame: up to 48 hours post-dose ]
    based on Peak Plasma Concentration (Cmax)

  2. Bioequivalence [ Time Frame: up to 48 hours post-dose ]
    based on Area under the plasma concentration versus time curve (AUC)



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
Criteria

Inclusion Criteria:

  • Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2.

Exclusion Criteria:

  • Smokers

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Responsible Party: Axim Biotechnologies
ClinicalTrials.gov Identifier: NCT03098940     History of Changes
Other Study ID Numbers: MedChew
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists