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Cannabidiol

New CBD Capsule vs Epidyolex for Healthy Adults

Phase 1
Waitlist Available
Led By Anthony Bier, MD
Research Sponsored by DSM Nutritional Products, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) range of 18.0 - 29.9 kg/m2 and body weight ≥ 50 kg
Healthy male or female participants who are 19 to 55 years of age
Must not have
Current COVID-19 infection at the time of screening or Visit 2, or currently have the post COVID-19 condition as defined by the World Health Organization (WHO)
Evidence of hepatic or renal dysfunction as evidenced by specific laboratory values at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum of 14 days, maximum of 28 days
Awards & highlights
No Placebo-Only Group

Summary

"This trial is looking at how a new capsule form of CBD compares to the already approved Epidyolex in terms of how the body processes it. The study will give participants both products in different conditions

Who is the study for?
This trial is for healthy adult volunteers interested in helping to study the effects of a new form of cannabidiol (CBD). Participants should be willing to take CBD under different eating conditions. Specific eligibility details are not provided, but typically include age range and health status requirements.
What is being tested?
The study is testing how a new capsule form of CBD called CBD-NE compares with Epidyolex, an FDA-approved oil-based CBD product. The test measures how the body absorbs each form when participants have eaten (fed) or haven't eaten (fasted), using a crossover design where everyone gets both treatments at different times.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight, and possibly some liver issues. Since this trial involves healthy volunteers, monitoring for any adverse reactions will be part of the safety assessment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18.0 and 29.9, and I weigh at least 50 kg.
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I am between 19 and 55 years old and healthy.
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I can swallow pills or capsules without chewing them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have COVID-19 or am experiencing long-term effects after having it.
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My liver or kidney tests are not normal.
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I haven't had major surgery in the last 3 months nor plan to during the study.
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I am a male planning to try for a child during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum of 14 days, maximum of 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 14 days, maximum of 28 days 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 (PK) Properties of CBD-NE compared to Epidyolex under Fed Conditions
Secondary study objectives
PK Properties of CBD-NE compared to Epidiolex under Fed Conditions
PK Properties of CBD-NE compared to Epidyolex under Fasted Conditions
PK Properties of CBD-NE compared to Epidyolex under Fed Conditions
+2 more
Other study objectives
Assessment of 12-lead electrocardiogram (ECG)
Blood pressure
Body Temperature
+39 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: TP Under Fasted ConditionExperimental Treatment1 Intervention
A single dose of CBD-NE (6 capsules) after a minimum 10-hour fast
Group II: CBD-NE Under Fed ConditionExperimental Treatment1 Intervention
A single dose of CBD-NE (6 capsules) following consumption of a high-fat, high-calorie breakfast
Group III: Epidyolex Under Fasted ConditionActive Control1 Intervention
A single dose of Epidyolex (4 mL oil) after a minimum 10-hour fast
Group IV: Epidyolex Under Fed ConditionActive Control1 Intervention
A single dose of Epidyolex (4 mL oil) following consumption of a high-fat, high-calorie breakfast

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

DSM Nutritional Products, Inc.Lead Sponsor
96 Previous Clinical Trials
57,202 Total Patients Enrolled
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
36 Previous Clinical Trials
2,082 Total Patients Enrolled
Anthony Bier, MDPrincipal InvestigatorApex Trials
7 Previous Clinical Trials
326 Total Patients Enrolled
~0 spots leftby Dec 2024
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