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• W2955396164 abstract "Abstract Objective To evaluate the pharmacokinetics of a purified oral cannabidiol ( CBD ) capsule administered with and without food in adults with refractory epilepsy. Methods Adult patients who were prescribed CBD for seizures, had localization‐related intractable epilepsy with ≥4 seizures per month, and qualified for Minnesota cannabis were enrolled. A single dose of 99% pure CBD capsules was taken under both fasting (no breakfast) and fed (high fat 840‐860 calorie) conditions. Blood sampling for CBD plasma concentrations was performed under each condition between 0 and 72 hours post‐dose and measured by a validated liquid chormatography‐mass spectometry assay. CBD pharmacokinetic profiles including maximum concentration ( C max ), area‐under‐the‐curve from zero to infinity ( AUC 0‐∞ ), and time‐to‐maximum concentration ( T max ) were calculated. The confidence intervals ( CI s) for log‐transformed C max and AUC 0‐∞ ratios between fed and fasting states were calculated. Seizure and adverse events information was collected. Results Eight patients completed the study. On average C max was 14 times and AUC 0‐∞ 4 times higher in the fed state. The 90% CI for the ratio of fed versus fast conditions for C max and AUC 0‐∞ were 7.47‐31.86 and 3.42‐7.82, respectively. No sequence or period effect for C max and AUC 0‐∞ was observed. No adverse events were reported. Significance Administering CBD as a capsule rather than a liquid allows for more precise determination of pharmacokinetics parameters and is more representative of CBD swallowed products. The fat content of a meal can lead to significant increases in C max and AUC 0‐∞ and can account for variability in bioavailability and overall drug exposure within patients with oral products." @default.
• W2955396164 created "2019-07-12" @default.
• W2955396164 creator A5003368399 @default.
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• W2955396164 date "2019-06-27" @default.
• W2955396164 modified "2023-10-16" @default.
• W2955396164 title "Food effect on pharmacokinetics of cannabidiol oral capsules in adult patients with refractory epilepsy" @default.
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• W2955396164 doi "https://doi.org/10.1111/epi.16093" @default.
• W2955396164 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31247132" @default.
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