A phase i study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray

European Journal of Clinical Pharmacology

Volumn 69, Issue 4, 2013, Pages 825-834

  Stott, C G ^a   White, L ^a   Wright, S ^a   Wilbraham, D ^b   Guy, G W ^a  

^a Porton Down Science Park   (United Kingdom)

^b GUY S HOSPITAL   (United Kingdom)

Author keywords

Cannabidiol; Cannabinoid; Delta 9 tetrahydrocannabinol; Endocannabinoid; Pharmacokinetics; THC CBD spray

Indexed keywords

11 HYDROXYDRONABINOL; CANNABIDIOL; DRONABINOL; DRUG METABOLITE;

ABNORMAL SENSATION; ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CONTROLLED STUDY; CROSSOVER PROCEDURE; DAYDREAMING; DIET RESTRICTION; DIZZINESS; DREAMING; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM; DRUG HALF LIFE; DRUG TOLERABILITY; DRY THROAT; EUPHORIA; FOOD; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; INCREASED APPETITE; MALE; MAXIMUM PLASMA CONCENTRATION; MOOD DISORDER; NORMAL HUMAN; OPEN STUDY; ORGANIC PSYCHOSYNDROME; OROMUCOSAL SPRAY; PARESTHESIA; PRIORITY JOURNAL; PROCEDURAL SITE REACTION; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; BIOLOGICAL AVAILABILITY; BREAKFAST; CANNABIDIOL; CROSS-OVER STUDIES; DIETARY FATS; DRUG COMBINATIONS; FASTING; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; MOUTH MUCOSA; ORAL SPRAYS; TETRAHYDROCANNABINOL; YOUNG ADULT;

EID: 84876703793     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1393-4     Document Type: Article

References (19)

1. MHRA Public Assessment Report (2012) Nabiximols oromucosal spray (delta-9-tetrahydrocannabinol and cannabidiol) - PL 18024/0009; UK/H/2462/001/DC
2. Porteney R, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT (2012) Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain 13(5):438-449
3. Young CA, Nurmikko TJ, Rog DJ, Sanantis N (2005) A randomised controlled trial of Sativex, a cannabis based medicine, in central neuropathic pain due to multiple sclerosis. Program and abstracts of the 2005 Canadian Association of Physical Medicine and Rehabilitation Annual Meeting; Ottawa, Ontario, Canada. Abstract A45
4. Whittle BA, Guy GW, Robson P (2001) Prospects for new cannabis-based prescription medicines. J Cannabis Ther 1(3-4):183-205
5. Howlett AC, Barth F, Bonner TI, Cabral G, Casellas P, Devane WA, Felder CC, Herkenham M, Mackie K, Martin BR, Mechoulam R, Pertwee RG (2002) International union of pharmacology. XXVII. Classification of cannabinoid receptors. Pharmacol Rev 54(2):161-202
6. Pertwee RG (2007) Cannabinoids and multiple sclerosis. Mol Neurobiol 36:45-59
7. FDA Guidance for Industry (2002) Food-effect bioavailability and fed bioequivalence studies. http://www.fda.gov/downloads/regulatoryinformation/ guidances/ucm126833.pdf Accessed December 2011
8. Foltz RL, McGinnis KM, Chinn DM (1983) Quantitative measurement of delta 9-tetrahydrocannabinol and two major metabolites in physiological specimens using capillary column gas chromatography negative ion chemical ionization mass spectrometry. Biochem MS 10(5):316-323
9. Goodall CR, Basteyns BJ (1995) A reliable method for the detection, confirmation, and quantitation of cannabinoids in blood. J Anal Tox 19:419-426
10. Kemp MP, Abukhalaf IK, Manno JE, Manno BR, Alford DD, Abusada GA (1995) Cannabinoids in humans. I. Analysis of delta-9-tetrahydrocannabinol and six metabolites in plasma and urine using GC-MS. J Anal Tox 19:285-291
11. FDA Guidance for Industry (2001) Bioanalytical method validation issued by the U.S Department of Health and Human Services Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070107.pdf. Accessed July 2012
12. Miller JC, Miller JN (1992) Statistics for analytical chemistry. Ellis Horwood, New York
13. Lindholm A, Henricsson S, Dahlqvist R (1990) The effect of food and bile acid administration on the relative bioavailability of cyclosporin. Br J Clin Pharmacol 29:541-548
14. Charman WN, Porter CJ, Mithani S, Dressman JB (1997) Physicochemical and physiological mechanisms for the effects of food on drug absorption: the role of lipids and pH. J Pharm Sci 86:269-282
15. Guy GW, Robson PJ (2003) A Phase I, open label, four-way crossover study to compare the pharmacokinetic profiles of a single dose of 20 mg of a Cannabis Based Medicine Extract (CBME) administered on 3 different areas of the buccal mucosa and to investigate the pharmacokinetics of CBME per oral in healthy male and female volunteers (GWPK0112). J Cannabis Ther 3/4:79-120
16. Guy GW, Robson PJ (2003) A Phase I, double blind, three-way crossover study to assess the pharmacokinetic profile of Cannabis Based Medicine Extract (CBME) administered sublingually in variant cannabinoid ratios in normal healthy male volunteers (GWPK0215). J Cannabis Ther 3/4:121-152
17. Patient Information Leaflet (2012) Sativex® Oromucosal Spray. http://www.medicines.org.uk/EMC/medicine/23228/PIL/. Accessed 9 August 2012
18. Gershkovich P, Hoffman A (2007) Effect of a high-fat meal on absorption and disposition of lipophilic compounds: the importance of degree of association with triglyceride-rich lipoproteins. Eur J Pharm Sci 32:24-32
19. Charman WN, Stella VJ (1992) Lymphatic transport of drug. CRC Press, Boca Raton