Pharmacokinetics and pharmacodynamics of cannabis-based medicine in a patient population included in a randomized, placebo-controlled, clinical trial.
Autor: | Hansen JS; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Boix F; Section for Drug Abuse Research, Department of Forensic Sciences, Division of Laboratory Medicine, Oslo University Hospital, Oslo, Norway., Hasselstrøm JB; Department of Forensic Medicine, Aarhus University, Aarhus, Denmark., Sørensen LK; Department of Forensic Medicine, Aarhus University, Aarhus, Denmark., Kjolby M; Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.; Department of Biomedicine, Aarhus University, Aarhus, Denmark., Gustavsen S; Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark., Hansen RM; Spinal Cord Injury Center of Western Denmark, Viborg, Denmark., Petersen T; Department of Neurology, Hospital of Southern Jutland and Research Unit in Neurology, Aabenraa, Denmark.; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark., Sellebjerg F; Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital - Rigshospitalet, Glostrup, Denmark., Kasch H; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Rasmussen PV; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark., Finnerup NB; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.; Danish Pain Research Centre, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Saedder EA; Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark.; Department of Biomedicine, Aarhus University, Aarhus, Denmark., Svendsen KB; Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. |
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Jazyk: | angličtina |
Zdroj: | Clinical and translational science [Clin Transl Sci] 2024 Jan; Vol. 17 (1), pp. e13685. Date of Electronic Publication: 2023 Dec 06. |
DOI: | 10.1111/cts.13685 |
Abstrakt: | Information on the pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered cannabis-based medicine (CBM) in capsule formulation in patient populations is sparse. In this exploratory study, we aimed to evaluate the PK and PD in a probable steady state of CBM in neuropathic pain and spasticity in a population of patients with multiple sclerosis (MS). Of 134 patients participating in a randomized, double-blinded, placebo-controlled, trial, 23 patients with MS (17 female) mean age 52 years (range 21-67) were enrolled in this substudy. They received oral capsules containing Δ 9 -tetrahydrocannabinol (THC, n = 4), cannabidiol (CBD, n = 6), a combination (THC&CBD, n = 4), or placebo (n = 9). Maximum doses were 22.5 mg (THC) and 45 mg (CBD) a day divided into three administrations. PD parameters were evaluated for pain and spasticity. Blood samples were analyzed using an ultra-high-performance liquid chromatography-tandem mass spectrometer after protein precipitation and phospholipid removal. PK parameters were estimated using computerized modeling. The variation in daily dose and PK between individuals was considerable in a steady state, yet comparable with previous reports from healthy controls. Based on a simulation of the best model, the estimated PK parameters (mean) for THC (5 mg) were C (© 2023 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.) |
Databáze: | MEDLINE |
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