Bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers

Clinical Pharmacology: Advances and Applications

Volumn 8, Issue , 2016, Pages 155-162

  Parikh, Neha ^a   Kramer, William G ^b   Khurana, Varun ^a   Cognata Smith, Christina ^a   Vetticaden, Santosh ^a  

^a INSYS Therapeutics Inc   (United States)

^b Kramer Consulting LLC   (United States)

Author keywords

Pharmacokinetics; Safety; Variability; 9 tetrahydrocannabinol

Indexed keywords

DRONABINOL;

ADULT; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSAGE FORM; DRUG ELIMINATION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LIQUID CHROMATOGRAPHY; MALE; NAUSEA; NORMAL HUMAN; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SOMNOLENCE; TANDEM MASS SPECTROMETRY;

EID: 84992109014     PISSN: None     EISSN: 11791438     Source Type: Journal    
DOI: 10.2147/CPAA.S115679     Document Type: Article

References (25)

1. Pertwee RG. Pharmacological actions of cannabinoids. Handb Exp Pharmacol. 2005;168:1-51.
2. Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-360.
3. Beal JE, Olson R, Lefkowitz L, et al. Long-term efficacy and safety of dronabinol for acquired immunodeficiency syndrome-associated anorexia. J Pain Symptom Manage. 1997;14(1):7-14.
4. Beal JE, Olson R, Laubenstein L, et al. Dronabinol as a treatment for anorexia associated with weight loss in patients with AIDS. J Pain Symptom Manage. 1995;10(2):89-97.
5. Lane M, Vogel CL, Ferguson J, et al. Dronabinol and prochlorperazine in combination for treatment of cancer chemotherapy-induced nausea and vomiting. J Pain Symptom Manage. 1991;6(6):352-359.
6. Plasse TF, Gorter RW, Krasnow SH, Lane M, Shepard KV, Wadleigh RG. Recent clinical experience with dronabinol. Pharmacol Biochem Behav. 1991;40(3):695-700.
7. Lucas VS Jr, Laszlo J. Delta 9-tetrahydrocannabinol for refractory vomiting induced by cancer chemotherapy. JAMA. 1980;243(12):1241-1243.
8. Orr LE, McKernan JF, Bloome B. Antiemetic effect of tetrahydrocannabinol. Compared with placebo and prochlorperazine in chemotherapy-associated nausea and emesis. Arch Intern Med. 1980;140(11):1431-1433.
9. Marinol® (dronabinol) capsules [package insert]. North Chicago, IL: AbbVie, Inc.; 2015.
10. Wall ME, Perez-Reyes M. The metabolism of delta 9-tetrahydrocannabinol and related cannabinoids in man. J Clin Pharmacol. 1981;21(8-9 suppl): 178S-189S.
11. Naef M, Curatolo M, Petersen-Felix S, Arendt-Nielsen L, Zbinden A, Brenneisen R. The analgesic effect of oral delta-9-tetrahydrocannabinol (THC), morphine, and a THC-morphine combination in healthy subjects under experimental pain conditions. Pain. 2003;105(1-2):79-88.
12. Ahmed AI, van den Elsen GA, Colbers A, et al. Safety and pharmacokinetics of oral delta-9-tetrahydrocannabinol in healthy older subjects: a randomized controlled trial. Eur Neuropsychopharmacol. 2014;24(9):1475-1482.
13. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657-680.
14. Haidar SH, Davit B, Chen ML, et al. Bioequivalence approaches for highly variable drugs and drug products. Pharm Res. 2008;25(1):237-241.
15. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research [webpage on the Internet]. Draft Guidance on Progesterone. 2011. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM209294.pdf. Accessed March 15, 2016.
16. Davit BM, Chen ML, Conner DP, et al. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration. AAPS J. 2012; 14(4):915-924.
17. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research [webpage on the Internet]. Draft Guidance on Dronabinol. 2014. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm199636.pdf. Accessed March 15, 2016.
18. US Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) [webpage on the Internet]. Guidance for Industry Bioavailability and Bioequivalance Studies Submitted in NDAs or INDs – General Considerations. 2014. Available from: http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm389370.pdf. Accessed March 15, 2016.
19. Ungerleider JT, Andrysiak T, Fairbanks L, Goodnight J, Sarna G, Jamison K. Cannabis and cancer chemotherapy: a comparison of oral delta-9-THC and prochlorperazine. Cancer. 1982;50(4):636-645.
20. Ekert H, Waters KD, Jurk IH, Mobilia J, Loughnan P. Amelioration of cancer chemotherapy-induced nausea and vomiting by delta-9-tetrahydrocannabinol. Med J Aust. 1979;2(12):657-659.
21. Frytak S, Moertel CG, O’Fallon JR, et al. Delta-9-tetrahydrocannabinol as an antiemetic for patients receiving cancer chemotherapy. A comparison with prochlorperazine and a placebo. Ann Intern Med. 1979;91(6): 825-830.
22. Kluin-Neleman JC, Neleman FA, Meuwissen OJ, Maes RA. delta 9-tetrahydrocannabinol (THC) as an antiemetic in patients treated with cancerchemotherapy; a double-blind cross-over trial against placebo. Vet Hum Toxicol. 1979;21(5):338-340.
23. Sallan SE, Cronin C, Zelen M, Zinberg NE. Antiemetics in patients receiving chemotherapy for cancer: a randomized comparison of delta-9-tetrahydrocannabinol and prochlorperazine. N Engl J Med. 1980;302(3):135-138.
24. Sallan SE, Zinberg NE, Frei EI. Antiemetic effect of delta-9-tetrahydrocannabinol in patients receiving cancer chemotherapy. N Engl J Med. 1975;293(16):795-797.
25. Chang AE, Shiling DJ, Stillman RC, et al. Delta-9-tetrahydrocannabinol as an antiemetic in cancer patients receiving high-dose methotrexate: a prospective, randomized evaluation. Ann Intern Med. 1979;91(6):819-824.