ArticleEuropean journal of clinical pharmacology2013
A phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray.
Article in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01322464 (A Phase I Study to Assess the Effect of Food on the Single-Dose Bioavailability of Sativex, and to Compare the Single and Multiple Dose Pharmacokinetics of Sativex at Three Dose Levels), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.
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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.
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.
A Phase I Study to Assess the Effect of Food on the Single-Dose Bioavailability of Sativex, and to Compare the Single and Multiple Dose Pharmacokinetics of Sativex at Three Dose Levels
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 68 citations in OpenAlex.
- Quantitative summary on the human pharmacokinetic properties of cannabidiol to accelerate scientific clinical application of cannabis.Naunyn-Schmiedeberg's archives of pharmacology · 2024Pooled it
- Pharmacokinetics of Cannabidiol: A Systematic Review and Meta-Regression Analysis.Cannabis and cannabinoid research · 2024Pooled it
- Effects of SativexNutrients · 2026Trial
- A randomized, double-blind, placebo-controlled, repeated-dose pilot study of the safety, tolerability, and preliminary effects of a cannabidiol (CBD)- and cannabigerol (CBG)-based beverage powder to support recovery from delayed onset muscle soreness (DOMS).Journal of the International Society of Sports Nutrition · 2023Trial
- The effects of cannabidiol on worry and anxiety among high trait worriers: a double-blind, randomized placebo controlled trial.Psychopharmacology · 2023Trial
- Trial
- A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorbMolecules (Basel, Switzerland) · 2019Trial
- Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia.Psychopharmacology · 2015Trial
- Article
- Cannabinoids in Cancer: Molecular Mechanisms of Tumor Cell Death and Translational Opportunities.Biomolecules · 2026Review
- Cannabinoids and drug-drug pharmacokinetic interactions: Deciphering the risks.British journal of clinical pharmacology · 2026Review
- Population pharmacokinetic modelling revealed large variability in oromucosal absorption of ΔBritish journal of clinical pharmacology · 2026Article
- Predicting Δ-9-Tetrahydrocannabinol-Induced Psychoactive and Cognitive Effects: A PBPK-PD Approach to Quantifying Feeling High and Reduced Alertness.ACS chemical neuroscience · 2025Article
- Pharmacokinetics and Side Effects of ΔKidney international reports · 2025Article
- A novel insight into the antidepressant effect of cannabidiol: possible involvement of the 5-HT1A, CB1, GPR55, and PPARγ receptors.The international journal of neuropsychopharmacology · 2025Review
- Pharmacokinetics of a single oral administration of two cannabidiol formulations in fed and fasted horses.Frontiers in veterinary science · 2025Article
- Strategies to Improve Cannabidiol Bioavailability and Drug Delivery.Pharmaceuticals (Basel, Switzerland) · 2024Review
- A cross-sectional survey on cannabis: Characterizing motives, opinions, and subjective experiences associated with the use of various oral cannabis products.Drug and alcohol dependence · 2023Article
- Cannabidiol and brain function: current knowledge and future perspectives.Frontiers in pharmacology · 2023Review
- Medical Cannabis Received by Patients According to Qualifying Condition in a US State Cannabis Program: Product Choice, Dosing, and Age-Related Trends.Current therapeutic research, clinical and experimental · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the effect of food on the single-dose bioavailability of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) spray, an endocannabinoid system modulator, when administered to healthy male subjects.
methodsTwelve subjects took part in this fed-fasted cross-over study and received a single dose of THC/CBD spray (4 sprays = 10.8 mg THC + 10 mg CBD) in the fasted then fed state (or vice versa) with a 3-day wash-out period between treatments. Plasma samples were collected at designated time-points for analysis of CBD, THC, and its active metabolite, 11-hydroxy delta-9-tetrahydrocannabinol (11-OH-THC).
resultsStatistically significant increases in the mean area under the curve (AUC) and mean maximum plasma drug concentration (Cmax) were observed in subjects during fed conditions. Mean AUC and Cmax were one to three-fold higher for THC and 11-OH-THC, and five and three-fold higher for CBD respectively during fed conditions. A large inter-subject variability in exposure from the same dose was observed, particularly for THC. The Cmax for THC in fed versus fasted subjects was higher in 7 subjects (4.80-14.91 ng/ml) and lower in 5 subjects (2.81-3.51 ng/ml) compared with the mean Cmax of 3.98 ng/ml (range 0.97-9.34 ng/ml) observed in the fasted state. Increases in mean AUC(0-t), AUC(0-inf), and Cmax for THC, CBD, and 11-OH-THC in the fed state were within the range of inter-subject variability, which was considerable. Food also appeared to delay the time to peak concentration (Tmax) of all analytes by approximately 2-2.5 h. Only mild adverse events were reported.
conclusionsThe THC/CBD spray was well tolerated in male subjects at a single dose of four sprays. The large inter-subject variability in exposure suggests that the changes observed are unlikely to be clinically relevant.
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