NCT03098940

Brief Summary

This study is a two part study

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 21, 2017

Last Update Submit

March 28, 2017

Conditions

THC

Outcome Measures

Primary Outcomes (2)

  • Bioequivalence

    based on Peak Plasma Concentration (Cmax)

    up to 48 hours post-dose

  • Bioequivalence

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

    up to 48 hours post-dose

Study Arms (2)

Chewing gum

EXPERIMENTAL

Chewing gum with various doses of dronabinol

Drug: Chewing Gum

Capsule (Marinol)

ACTIVE COMPARATOR

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

Drug: Chewing Gum

Interventions

Chewing GumDRUG

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

Capsule (Marinol)Chewing gum

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 4, 2017

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

September 1, 2018

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share