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Cannabinoid

Cannabidiol Formulations for Healthy Adults

Phase 1

Recruiting

Led By Payam Dehghani, MD

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 - 35 years old

No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator

Must not have

History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure

History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week of samples will be collected. 2 week washout. then another week of samples after cross over

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare how well a new fast-dissolving cannabidiol strip on the cheek is absorbed compared to cannabidiol powder. The study will help determine the best way to

Who is the study for?

This trial is for healthy male adults interested in participating in a study to compare the absorption of two CBD formulations. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

What is being tested?

The trial is testing the relative bioavailability (how well a drug gets absorbed into the bloodstream) of two orally administered CBD products: a fast-dissolving cheek strip versus powder form. The goal is to determine which method delivers CBD more effectively.

What are the potential side effects?

While specific side effects are not listed, common side effects of cannabidiol may include tiredness, diarrhea, changes in appetite/weight, and potential interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 35 years old.

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I don't have any significant health issues apart from my current condition.

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I can stay in the clinic for 13 hours on treatment days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart condition.

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I do not have significant liver, kidney, or stomach diseases that affect drug processing.

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I cannot attend all required study visits.

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I haven't taken any strong painkillers like Morphine in the last week.

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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week of samples will be collected. 2 week washout. then another week of samples after cross over

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week of samples will be collected. 2 week washout. then another week of samples after cross over

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week of samples will be collected. 2 week washout. then another week of samples after cross over for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetic Parameters

Secondary study objectives

Compare Fed vs Fast state on oral absorption kinetics

Optimal washout periods

Safety of the drug using the Integrated Addendum to ICH E6(R1)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulationsActive Control1 Intervention

participants receiving the buccal formulation will be required to receive 10 strips by the cheeks, they will be instructed to only swallow at maximum once every 2 mins for the first 5 mins. This is to minimize the amount of CBD that will be carried into the GIT. This buccal administration group will receive 2 strips at a time, one on each cheek side, following 5 mins of dissolving, patients will receive 100mL of water to swish the residue in their mouths and swallow, then receive another pair of strips to repeat the process for a total of 5 times over the course of 30 minutes (i.e., 10 strips total). The group receiving the 1000mg oral CBD extract will mimic the buccal group in that they will receive that dose over the course of 30 minutes in 5 parts, 200mg per part, and will drink 100mL of water to accompany its administration

Group II: Single Oral Dose Administration of 3000mg CBD Extract in Fed vs FastingActive Control1 Intervention

In the fasting group, participants will be asked to fast overnight (at least 10 hours fast) but are allowed to drink water.In the fed state group, participants will start their meal 30 minutes prior to receiving the dose. The meal will consist of high caloric (800-1000 Cal), high fat (\~50% of total calories), with protein, and carbohydrates (\~150 kcal, and \~250 kcal, respectively) content. No food will be administered 4 hours after the dose, and no water will be given 1 hour prior to dose administration and 1 hour after administration. The dose will be given however with a total of 235 mL of water.

0 / 8Eligibility criteria met