What topics does this cannabis study cover?

This study covers research on: CBD.

Where was this research published?

Published in CNS drugs on May 1, 2026.

New CBD formulation absorbs faster with more consistent results

Q: What did this Clinical Trial find?

This Phase I clinical trial compared two different *cannabidiol* (CBD) formulations to understand how the body processes them. The study evaluated **CBtru®**, a new powdered emulsion formulation, against **Epidyolex®**, an established oil-based CBD product, in healthy adults who received **400-mg do

Comparative Pharmacokinetics and Safety of Cannabidiol in a Powder Formulation, CBtru®, vs an Oil-Based Formulation, Epidyolex®, Under Fasted and Fed Conditions in Healthy Participants: A Randomized Open-Label Cross-Over Phase I Study.

CNS drugs • May 1, 2026 • Clinical Trial • Moderately Relevant

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AI Summary

This Phase I clinical trial compared two different cannabidiol (CBD) formulations to understand how the body processes them. The study evaluated CBtru®, a new powdered emulsion formulation, against Epidyolex®, an established oil-based CBD product, in healthy adults who received 400-mg doses under both fasted and fed conditions. The research revealed that CBtru® absorbs faster (reaching peak levels in 3-5 hours compared to 3.5-8 hours) and produces more consistent blood levels, which could mean more predictable therapeutic effects for patients. Both formulations performed well nutritionally, with food intake significantly boosting CBD absorption overall, but CBtru® maintained an advantage in absorption speed regardless of eating status.

The key advantage of CBtru® lies in its lower variability between individuals and more predictable pharmacokinetics, particularly in fasted conditions. Under fasted conditions, CBtru® showed higher exposure to active metabolites (7-OH-CBD and 7-COOH-CBD), which are compounds the body produces when processing CBD. This matters because these metabolites may contribute to CBD's therapeutic effects. In fed conditions, both formulations performed comparably in terms of drug exposure, though CBtru® still achieved peak concentrations more quickly. Importantly, both formulations were well-tolerated with no safety concerns, suggesting the new formulation could offer patients a more reliable alternative to existing CBD products.

These findings have practical significance for CBD users seeking consistent therapeutic benefits. The more predictable pharmacokinetic profile of CBtru® could help healthcare providers better tailor doses for conditions like pediatric epilepsy (where CBD is already approved), chronic pain, and psychiatric disorders. The faster absorption time also means patients might experience effects more quickly. The reduced interindividual variability suggests that CBtru® may work more consistently across different people, potentially reducing the trial-and-error process many patients currently experience when finding their optimal CBD dose.

📄 Original Abstract

Emerging evidence indicates that cannabidiol (CBD) may offer meaningful therapeutic benefits across neurological, pain, and psychiatric disorders. Cannabidiol is already approved for the treatment of pediatric epilepsy. Owing to its high lipophilicity, it is typically delivered in oil-based formulations to overcome the low oral bioavailability of pure CBD. However, pharmacokinetic (PK) and safety data remain limited across different CBD formulations. This study evaluated the PK profile, tolerability, and safety of an encapsulated powdered emulsion formulation (CBtru®) compared with a marketed oil-based formulation (Epidyolex®/Epidiolex®) under fasted and fed conditions in healthy adults. This Phase I, single-center, open-label, randomized, 4-way crossover PK trial was conducted in healthy adults. All participants received a single 400-mg dose of CBtru® and Epidyolex® under both fasted and fed conditions, with a minimum 14-day washout between administrations. Pharmacokinetic parameters and safety were assessed throughout. Under fasted conditions, CBtru® trended to higher CBD exposure (AUC0-24) and maximum concentration in plasma (Cmax) relative to Epidyolex®. CBtru® demonstrated significantly greater metabolite exposure (7-OH-CBD, 7-COOH-CBD), along with higher active drug exposure (ADE = CBD + 7-OH-CBD) and higher total drug exposure (TDE=CBD + 7-OH-CBD + 7-COOH-CBD). Median tmax was shorter with CBtru® (3 h vs 3.5 h), indicating faster absorption. In line with previous studies, CBD exposure and concentrations were significantly higher in fed rather than in fasted conditions. Under fed conditions, median tmax was shorter with CBtru® (5 h vs 8 h), while CBD and metabolite exposure were comparable. CBtru® also showed lower interindividual variability in plasma CBD profiles, suggesting more predictable PK across both conditions. Both formulations were well tolerated, with no safety concerns reported. Both formulations demonstrated distinct PK profiles under fasted and fed conditions. CBtru® showed comparable bioavailability to Epidyolex®, with faster absorption in fasted and fed conditions, higher metabolite exposure in fasted conditions, and more consistent systemic levels in the fasted condition. These findings support further development of CBtru® as a novel oral CBD formulation for clinical use in relevant indications. gov ID number: NCT06578455.

Paper Type

🧪 Clinical Trial

Publication

Journal: CNS drugs
Published: May 1, 2026
PMID: 41888503
DOI: 10.1007/s40263-026-01280-1

Authors (14)

Igor Bendik Health Nutrition & Care, dsm-firmenich, Wurmisweg 576, Campus Building 245, 4303, Kaiseraugst, Switzerland. igor.bendik@dsm-firmenich.com.
Mareike Beck Science & Research, dsm-firmenich, Kaiseraugst, Switzerland.
Anu Manderna Nutrasource Pharmaceutical & Nutraceutical Services Inc., Guelph, ON, Canada.
Franz F Roos Science & Research, dsm-firmenich, Kaiseraugst, Switzerland.
Jun Wang Nutrasource Pharmaceutical & Nutraceutical Services Inc., Guelph, ON, Canada.
+9 more authors