A Bioavailability Study on Dronabinol

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

This study is a two part study

Study Overview

• Status: Unknown
• Conditions: THC
• Intervention / Treatment: Drug: Chewing Gum

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Axim Biotechnologies

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MedChew

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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