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

Study Description

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

Study Design

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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

Genetic and Rare Diseases Information Center resources: Oculocerebral Syndrome With Hypopigmentation

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Axim Biotechnologies
ClinicalTrials.gov Identifier:	NCT03098940
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

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