A Bioavailability Study on Dronabinol

NCT ID: NCT03098940

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-09-30

Brief Summary

This study is a two part study

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

Conditions

THC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chewing gum

Chewing gum with various doses of dronabinol

Group Type: EXPERIMENTAL

Chewing Gum

Intervention Type: DRUG

During the study healthy subjects will receive single doses of the various strengths of dronabinol

Capsule (Marinol)

Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol

Group Type: ACTIVE_COMPARATOR

Chewing Gum

Intervention Type: DRUG

During the study healthy subjects will receive single doses of the various strengths of dronabinol

Interventions

Chewing Gum

During the study healthy subjects will receive single doses of the various strengths of dronabinol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Axim Biotechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MedChew

Identifier Type: -

Identifier Source: org_study_id