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Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule) for Healthy Subjects

Phase < 1
Waitlist Available
Led By Igor Koturbash, MD, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 days
Awards & highlights
No Placebo-Only Group

Summary

This trial involves healthy adults taking CBD capsules over a short period to measure CBD levels in their blood. The goal is to understand how the body processes CBD. Participants must be between 18-45 years old and free from cannabinoid use for a while. Cannabidiol (CBD) has been studied in various formulations and dosages for its safety and tolerability in both healthy volunteers and patients with conditions like epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 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
Amount of 11-OH-THC in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
Amount of CBD in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
Amount of CBD-OH in plasma of healthy volunteers that have ingested hemp extract/CBD for 10 consecutive days using LCMS
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: 50 mg/day dose of Happy Lane CBD (Larger Dose)Experimental Treatment1 Intervention
Two 25 mg Happy Lane CBD gel capsules per day (50 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days. Both capsules will be taken at the same time as each other.
Group II: 25 mg/day dose of Happy Lane CBD (Lower Dose)Experimental Treatment1 Intervention
One 25 mg Happy Lane CBD gel capsule per day (25 mg/day total dose) for 10 consecutive days at approximately the same time of day (±1 hour) on each of these days.

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Who is running the clinical trial?

University of ArkansasLead Sponsor
494 Previous Clinical Trials
150,547 Total Patients Enrolled
Igor Koturbash, MD, PhDPrincipal InvestigatorUniversity of Arkansas
~0 spots leftby Nov 2025
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