A Bioavailability Study on Dronabinol

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03098940

Enrollment

Registered

2017-04-04

Start date

2018-01-31

Completion date

2018-09-30

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

THC

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

Interventions

DRUGChewing Gum

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bioequivalence	up to 48 hours post-dose	based on Peak Plasma Concentration (Cmax)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026