Trial reportEuropean journal of clinical pharmacology2013
A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray.
Trial report 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 53 papers, 5 of them syntheses that pooled 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.
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
53 citing papers in PubMed, 5 syntheses or guidelines pooled it, 116 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
- [Cannabis and cannabinoids for the treatment of acute and chronic pain].Der Anaesthesist · 2021Pooled it
- Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.Pharmacotherapy · 2021Pooled it
- Are cannabidiol and Δ(9) -tetrahydrocannabivarin negative modulators of the endocannabinoid system? A systematic review.British journal of pharmacology · 2015Pooled it
- Assessment of Orally Administered Δ9-Tetrahydrocannabinol When Coadministered With Cannabidiol on Δ9-Tetrahydrocannabinol Pharmacokinetics and Pharmacodynamics in Healthy Adults: A Randomized Clinical Trial.JAMA network open · 2023Trial
- Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.Journal of analytical toxicology · 2022Trial
- A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorbMolecules (Basel, Switzerland) · 2019Trial
- Oral Cannabidiol does not Alter the Subjective, Reinforcing or Cardiovascular Effects of Smoked Cannabis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2016Trial
- Media reporting in Ireland on medicines derived from the hemp plant Cannabis sativa L.Irish journal of medical science · 2026Article
- Predicting Cannabidiol Pharmacokinetics in Older Adults Via Physiologically Based Pharmacokinetic Modeling.The AAPS journal · 2026Article
- Population pharmacokinetic modelling revealed large variability in oromucosal absorption of ΔBritish journal of clinical pharmacology · 2026Article
- From Screening to a Nanotechnological Platform: Cannabidiol-Chemotherapy Co-Loaded Lipid Nanocapsules for Glioblastoma Multiforme Treatment.Pharmaceutics · 2025Article
- Randomized single-dose crossover comparative bioavailability study of two novel oral cannabidiol (CBD) formulations in healthy volunteers under fed conditions, compared to a standard CBD isolate capsule.Journal of cannabis research · 2025Article
- Neurologists' perspectives of cannabis-based medicines: results from an all-Ireland survey.Irish journal of medical science · 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
- Cumulative Effects of Cannabis Oils on Body Temperature, Electrocardiography, Heart Rate Variability, Blood Pressure, and Respiratory Function in Telemetered Dogs.International journal of veterinary science and medicine · 2025Article
- Polycaprolactone microparticles for the subcutaneous administration of cannabidiol: in vitro and in vivo release.Drug delivery and translational research · 2024Article
- Drug Interactions of Tetrahydrocannabinol and Cannabidiol in Cannabinoid Drugs.Deutsches Arzteblatt international · 2023Review
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 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeA Phase I study to assess the single and multipledose pharmacokinetics (PKs) and safety and tolerability of oromucosally administered Δ(9)-tetrahydrocannabinol (THC)/cannabidiol (CBD) spray, an endocannabinoid system modulator, in healthy male subjects.
methodsSubjects received either single doses of THC/CBD spray as multiple sprays [2 (5.4 mg THC and 5.0 mg CBD), 4 (10.8 mg THC and 10.0 mg CBD) or 8 (21.6 mg THC and 20.0 mg CBD) daily sprays] or multiple doses of THC/CBD spray (2, 4 or 8 sprays once daily) for nine consecutive days, following fasting for a minimum of 10 h overnight prior to each dosing. Plasma samples were analyzed by gas chromatography-mass spectrometry for CBD, THC, and its primary metabolite 11-hydroxy-THC, and various PK parameters were investigated.
resultsΔ(9)-Tetrahydrocannabinol and CBD were rapidly absorbed following single-dose administration. With increasing single and multiple doses of THC/CBD spray, the mean peak plasma concentration (Cmax) increased for all analytes. There was evidence of dose-proportionality in the single but not the multiple dosing data sets. The bioavailability of THC was greater than CBD at single and multiple doses, and there was no evidence of accumulation for any analyte with multiple dosing. Inter-subject variability ranged from moderate to high for all PK parameters in this study. The time to peak plasma concentration (Tmax) was longest for all analytes in the eight spray group, but was similar in the two and four spray groups. THC/CBD spray was well-tolerated in this study and no serious adverse events were reported.
conclusionsThe mean Cmax values (<12 ng/mL) recorded in this study were well below those reported in patients who smoked/inhaled cannabis, which is reassuring since elevated Cmax values are linked to significant psychoactivity. There was also no evidence of accumulation on repeated dosing.
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Registered trials
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.