A Bioavailability Study on Dronabinol

Axim Biotechnologies50 enrolled

Overview

This study is a two part study

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

THC

Interventions

Chewing GumDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioequivalence

based on Peak Plasma Concentration (Cmax)

Time frame: up to 48 hours post-dose

Bioequivalence

based on Area under the plasma concentration versus time curve (AUC)

Time frame: up to 48 hours post-dose

Data from ClinicalTrials.gov

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