A Bioavailability Study on Dronabinol

THC Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03098940
• Other study ID #: MedChew
• 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
• 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

Related Conditions & MeSH terms

• THC

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