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Verified March 2017 by Axim Biotechnologies


Information provided by (Responsible Party):

Axim Biotechnologies

ClinicalTrials.gov Identifier:


First received: March 21, 2017

Last updated: March 28, 2017

Last verified: March 2017

This study is a two part study

THC Drug: Chewing Gum Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
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

Primary Outcome Measures:

Estimated Enrollment: 50
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
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

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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

Responsible Party: Axim Biotechnologies
ClinicalTrials.gov Identifier: NCT03098940     History of Changes
Other Study ID Numbers: MedChew
Study First Received: March 21, 2017
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

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:

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

ClinicalTrials.gov processed this record on April 05, 2017