Evidence map›Paper›PMID 32012251›Full record

Trial reportEpilepsia2020

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects.

Julie Crockett, David Critchley, Bola Tayo, Joris Berwaerts, Gilmour Morrison

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 5 pooled it
6.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 5 syntheses or guidelines pooled it, 73 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Julie CrockettGW Research Ltd, Cambridge, UK.
David CritchleyGW Research Ltd, Cambridge, UK.
Bola TayoGW Research Ltd, Cambridge, UK.
Joris BerwaertsGW Research Ltd, Cambridge, UK.
Gilmour MorrisonGW Research Ltd, Cambridge, UK.
GW Pharmaceuticals (United Kingdom) · GB

Funding

GW Research Ltd
6 · The paper itself

Abstract

objectiveThe pharmacokinetics (PK) and safety of single oral 750-mg doses of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the USA and Epidyolex in Europe; 100-mg/mL oral solution) were assessed in healthy adults following a high-fat/calorie meal (n = 15), a low-fat/calorie meal (n = 14), whole milk (n = 15), or alcohol (n = 14), relative to the fasted state (n = 29).

methodsBlood samples were collected until 96 hours postdose in each period and evaluated by liquid chromatography and tandem mass spectrometry. PK parameters (maximum observed plasma concentration [C

resultsCBD exposure increased by 3.8-fold for AUC SIGNIFICANCE: CBD and metabolite exposures were most affected by a high-fat/calorie meal. CBD exposures also increased with a low-fat/calorie meal, whole milk, or alcohol, but to a lesser extent. CBD was tolerated, and there were no severe or serious adverse events during the trial.

Indexed as

Alcoholic BeveragesMealsMilkAdultAgedAnimalsAnticonvulsantsArea Under CurveBiological AvailabilityBiotransformationCannabidiolChromatography, High Pressure LiquidCross-Over StudiesDietary FatsEnergy IntakeFemaleAnticonvulsantsCannabidiolDietary Fatsalcoholcannabidiolcannabinoidfood effectpharmacokinetics

Identifiers

PMID32012251
PMCPMC7065230
OpenAlexW3004381441

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.