A Randomized, Single-Dose, Single-Sequence, Two-Arm (Fasting and Fed), Open-Label Study on the Oral Pharmacokinetics of a Nanodispersible Cannabidiol Solution (150 mg/mL)

Prasad Rao Gundugurti; Monila Nadikudi; Ramyasree Thatikonda; Nagaraju Banda; Siva Sankara Rao Yadlapalli; Arjun Narala; Chandrashekhar Kocherlakota; Kumar S D Kothapalli

doi:10.1159/000550104

A Randomized, Single-Dose, Single-Sequence, Two-Arm (Fasting and Fed), Open-Label Study on the Oral Pharmacokinetics of a Nanodispersible Cannabidiol Solution (150 mg/mL)

Med Cannabis Cannabinoids. 2025 Dec 18;9(1):20-29. doi: 10.1159/000550104. eCollection 2026 Jan-Dec.

Authors

Prasad Rao Gundugurti¹, Monila Nadikudi², Ramyasree Thatikonda², Nagaraju Banda², Siva Sankara Rao Yadlapalli², Arjun Narala², Chandrashekhar Kocherlakota², Kumar S D Kothapalli³

Affiliations

¹ Asha Hospital, Hyderabad, India.
² Leiutis Pharmaceuticals LLP, Hyderabad, India.
³ Biophore Pharma Inc, Monmouth Junction, NJ, USA.

Abstract

Introduction: Cannabidiol (CBD), a non-psychoactive phytocannabinoid, attributed to its therapeutic benefits and positive safety profile is being studied for its potential to treat various medical conditions. The low oral bioavailability and significant first-pass metabolism present pharmacokinetic (PK) challenges. The present study aimed to evaluate the PK profile of a novel nanodispersible CBD oral solution (150 mg/mL) under fasting and fed conditions in healthy male subjects.

Methods: In this randomized, single-dose, two-arm (fasting and fed), open-label trial, 18 subjects (9 fasting and 9 fed) received 300 mg of CBD (2 mL of 150 mg/mL). Plasma concentrations of CBD and its major metabolites, specifically 7-hydroxy-cannabidiol (7-OH-CBD) and 7-carboxy-cannabidiol (7-COOH-CBD) were quantified and the PK parameters including C_max, time to reach maximum concentration (T_max), AUC_0-∞, and t½ were analyzed using non-compartmental modeling methods.

Results: The fed state significantly increased the area under the curve (AUC_0-∞) for CBD by 3.0-fold (p < 0.0001) and prolonged the T_max. C_max was moderately higher in the fed state (1.3-fold). The 7-COOH-CBD metabolite reached the highest plasma concentration, followed by the parent CBD and 7-OH-CBD. The administration of nanodispersible CBD oral solution was well tolerated, with no major adverse events.

Conclusions: The nanodispersible CBD oral solution showed enhanced bioavailability under fed conditions and was well tolerated in healthy subjects. Food intake increased CBD's C_max and AUC and delayed T_max. Further studies are required to confirm the therapeutic efficacy in patient populations.

Keywords: Cannabidiol; Fasting; Fed state; Nanodispersible formulation; Pharmacokinetics.