Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03098940
Other study ID # MedChew
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received March 21, 2017
Last updated March 28, 2017
Start date January 2018
Est. completion date September 2018

Study information

Verified date March 2017
Source Axim Biotechnologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a two part study


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Chewing Gum
During the study healthy subjects will receive single doses of the various strengths of dronabinol

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Axim Biotechnologies

Outcome

Type Measure Description Time frame Safety issue
Primary Bioequivalence based on Peak Plasma Concentration (Cmax) up to 48 hours post-dose
Primary Bioequivalence based on Area under the plasma concentration versus time curve (AUC) up to 48 hours post-dose
See also
  Status Clinical Trial Phase
Completed NCT04976738 - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain Phase 1/Phase 2
Not yet recruiting NCT06378957 - Behavioral Pharmacology of Orally Administered THC and D-limonene Phase 1
Active, not recruiting NCT03560934 - Tetrahydrocannabinol (THC) and Sleep Early Phase 1
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT04130633 - Behavioral Pharmacology of THC and Alpha-pinene Phase 1
Completed NCT05121506 - A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults Phase 1
Completed NCT04360044 - Efficacy of Inhaled Cannabis for Acute Migraine Treatment Phase 2
Withdrawn NCT04340700 - Characterization of the Pharmacodynamic Response to Vaped THC Phase 3
Not yet recruiting NCT06099379 - Modulation of THC Effects by CBD: a Dose-ranging Study Phase 1/Phase 2
Completed NCT04851392 - Do Adolescents and Adults Differ in Their Acute Response to Cannabis? N/A
Completed NCT04294966 - Age-Related Effects of THC Early Phase 1
Recruiting NCT05116527 - THC Memory & Reward Learning Pilot Phase 1/Phase 2
Recruiting NCT05514899 - Effects of Cannabidiol and Tetrahydrocannabinol on Microbiome and Neuroinflammation in HIV Phase 2
Active, not recruiting NCT02102113 - Probing the Cannabinoid System in Individuals With a Family History of Psychosis Early Phase 1
Not yet recruiting NCT06077292 - Cannabis THC Potency, Metabolism, and Cognitive Impairment in Young Adults N/A
Suspended NCT05427630 - Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment Phase 2
Not yet recruiting NCT05641766 - Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks Phase 2