A Bioavailability Study on Dronabinol

Axim Biotechnologies

Status and phase: Unknown; Phase 1

Conditions: THC

Treatments: Drug: Chewing Gum

Study type: Interventional

Funder types: Industry

Identifiers

NCT03098940

MedChew

Details and patient eligibility

About

This study is a two part study

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Chewing gum

Experimental group

Description:

Chewing gum with various doses of dronabinol

Treatment:

Drug: Chewing Gum

Capsule (Marinol)

Active Comparator group

Description:

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

Treatment:

Drug: Chewing Gum