<p>Cannabidiol (CBD), a specialized metabolite (phytocannabinoid) abundant in <i>Cannabis sativa</i>, is attracting increasing attention for its alleged health-promoting properties. The present study aimed to investigate the pharmacokinetics of CBD and its primary metabolite, 7‐hydroxy‐cannabidiol (7-OH-CBD), following a single oral dose of a CBD-rich Cannabis sativa extract, equivalent to 70 mg CBD, in healthy male (n=5) and female (n=6) participants. Using a randomized crossover design, the study evaluated the impact of a standardized high-fat meal compared to fasting on the oral bioavailability of CBD. Consumption of a high-fat meal significantly increases the bioavailability of CBD. The geometric mean ratio (GMR) of CBD C<sub>max</sub> was 17.4 (90% CI 12.4–24.2 and of the AUC 9.7 (90% CI 7.7–12.3), demonstrating a substantial increase in peak concentration and total CBD exposure under fed conditions. A notable double peak phenomenon was observed after meal consumption, with a less pronounced effect in the fasted state. This contributes to sustained high plasma concentrations and may be (partially) attributed to lymphatic transport, enterohepatic recirculation, and/or a secondary meal effect.</p><p>This trial was registered on October 19, 2020, with ClinicalTrials.gov under the identifier NCT04589455. The registration title is: Determination of Pharmacokinetics and Food-effect of CBD from a Hemp Extract in Healthy Human Volunteers.</p>

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A high-fat meal significantly impacts the bioavailability and biphasic absorption of cannabidiol (CBD) from a CBD-rich extract in men and women

  • Bo Anne Daniëlla Frederique Saals,
  • Tessa Helena De Bie,
  • Eral Osmanoglou,
  • Ties van de Laar,
  • Adriaan Willem Tuin,
  • Anne Claire Benedikte van Orten-Luiten,
  • Renger Frederik Witkamp

摘要

Cannabidiol (CBD), a specialized metabolite (phytocannabinoid) abundant in Cannabis sativa, is attracting increasing attention for its alleged health-promoting properties. The present study aimed to investigate the pharmacokinetics of CBD and its primary metabolite, 7‐hydroxy‐cannabidiol (7-OH-CBD), following a single oral dose of a CBD-rich Cannabis sativa extract, equivalent to 70 mg CBD, in healthy male (n=5) and female (n=6) participants. Using a randomized crossover design, the study evaluated the impact of a standardized high-fat meal compared to fasting on the oral bioavailability of CBD. Consumption of a high-fat meal significantly increases the bioavailability of CBD. The geometric mean ratio (GMR) of CBD Cmax was 17.4 (90% CI 12.4–24.2 and of the AUC 9.7 (90% CI 7.7–12.3), demonstrating a substantial increase in peak concentration and total CBD exposure under fed conditions. A notable double peak phenomenon was observed after meal consumption, with a less pronounced effect in the fasted state. This contributes to sustained high plasma concentrations and may be (partially) attributed to lymphatic transport, enterohepatic recirculation, and/or a secondary meal effect.

This trial was registered on October 19, 2020, with ClinicalTrials.gov under the identifier NCT04589455. The registration title is: Determination of Pharmacokinetics and Food-effect of CBD from a Hemp Extract in Healthy Human Volunteers.