메뉴 건너뛰기




Volumn 34, Issue 7, 2012, Pages 1601-1612

Dose Proportionality and the Effects of Food on Bioavailability of an Immediate-Release Oxycodone Hydrochloride Tablet Designed to Discourage Tampering and Its Relative Bioavailability Compared With a Marketed Oxycodone Tablet Under Fed Conditions: A Single-Dose, Randomized, Open-Label, 5-Way Crossover Study in Healthy Volunteers

Author keywords

[No Author keywords available]

Indexed keywords

FAT; NALTREXONE; OXYCODONE;

EID: 84863821865     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.05.009     Document Type: Article
Times cited : (13)

References (27)
  • 3
    • 84872605210 scopus 로고    scopus 로고
    • RADARS system data indicate immediate release opioids responsible for higher proportion of misuse, abuse and diversion than extended release opioids
    • Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS®) System
    • RADARS system data indicate immediate release opioids responsible for higher proportion of misuse, abuse and diversion than extended release opioids. RADARS System News 2009, 4:1. Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS®) System.
    • (2009) RADARS System News , vol.4 , pp. 1
  • 4
    • 33845934721 scopus 로고    scopus 로고
    • Motives, diversion and routes of administration associated with nonmedical use of prescription opioids
    • McCabe S.E., Cranford J.A., Boyd C.J., Teter C.J. Motives, diversion and routes of administration associated with nonmedical use of prescription opioids. Addict Behav 2007, 32:562-575.
    • (2007) Addict Behav , vol.32 , pp. 562-575
    • McCabe, S.E.1    Cranford, J.A.2    Boyd, C.J.3    Teter, C.J.4
  • 5
    • 6344262302 scopus 로고    scopus 로고
    • A profile of OxyContin addiction
    • Hays L.R. A profile of OxyContin addiction. J Addict Dis 2004, 23:1-9.
    • (2004) J Addict Dis , vol.23 , pp. 1-9
    • Hays, L.R.1
  • 6
    • 70349217277 scopus 로고    scopus 로고
    • Seeking drug treatment for OxyContin abuse: a chart review of consecutive admissions to a substance abuse treatment facility in Kentucky
    • Hays L., Kirsh K.L., Passik S.D. Seeking drug treatment for OxyContin abuse: a chart review of consecutive admissions to a substance abuse treatment facility in Kentucky. J Natl Compr Canc Netw 2003, 1:423-428.
    • (2003) J Natl Compr Canc Netw , vol.1 , pp. 423-428
    • Hays, L.1    Kirsh, K.L.2    Passik, S.D.3
  • 7
    • 77957922787 scopus 로고    scopus 로고
    • Route of administration for illicit prescription opioids: a comparison of rural and urban drug users
    • Young A.M., Havens J.R., Leukefeld C.G. Route of administration for illicit prescription opioids: a comparison of rural and urban drug users. Harm Reduct J 2010, 7:24.
    • (2010) Harm Reduct J , vol.7 , pp. 24
    • Young, A.M.1    Havens, J.R.2    Leukefeld, C.G.3
  • 8
    • 84872620999 scopus 로고    scopus 로고
    • National Institutes of Health, National Institute on Drug Abuse, Accessed December 16, 2011
    • Trends and statistics National Institutes of Health, National Institute on Drug Abuse, Accessed December 16, 2011. http://www.drugabuse.gov/drugpages/stats.html.
    • Trends and statistics
  • 9
    • 34249908675 scopus 로고    scopus 로고
    • King Pharmaceuticals, Bristol, TN, Accessed April 6, 2012
    • Oxecta [prescribing information] June 2011, King Pharmaceuticals, Bristol, TN, Accessed April 6, 2012. http://labeling.pfizer.com/ShowLabeling.aspx?id=620.
    • (2011) Oxecta [prescribing information]
  • 10
    • 84859189857 scopus 로고    scopus 로고
    • Acura Pharmaceuticals, Inc., Accessed April 10, 2012
    • Aversion Technology Acura Pharmaceuticals, Inc., Accessed April 10, 2012. http://acurapharm.com/research-development/aversion-technology/.
    • Aversion Technology
  • 13
    • 84896390873 scopus 로고    scopus 로고
    • A single-dose, 3-way crossover pharmacokinetic comparison between immediate-release oxycodone hydrochloride with aversion technology (IRO-A, Oxecta), IRO-A with niacin, and oxycodone hydrochloride (Roxicodone) in healthy adults under fasting conditions
    • [Epub ahead of print]
    • Leibowitz M.T., Zamora C.A., Brzeczko A.W., Stark J.G. A single-dose, 3-way crossover pharmacokinetic comparison between immediate-release oxycodone hydrochloride with aversion technology (IRO-A, Oxecta), IRO-A with niacin, and oxycodone hydrochloride (Roxicodone) in healthy adults under fasting conditions. Am J Ther 2012 Feb 18, [Epub ahead of print].
    • (2012) Am J Ther
    • Leibowitz, M.T.1    Zamora, C.A.2    Brzeczko, A.W.3    Stark, J.G.4
  • 14
    • 84872610611 scopus 로고    scopus 로고
    • International Conference on Harmonisation, 1996, Accessed April 6, 2012
    • ICH Topic E6 (R1) Guideline for Good Clinical Practice International Conference on Harmonisation, 1996, Accessed April 6, 2012. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf.
    • ICH Topic E6 (R1) Guideline for Good Clinical Practice
  • 15
    • 0242350785 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Accessed April 16, 2012
    • Guidance for industry: food-effect bioavailability and fed bioequivalence studies US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Accessed April 16, 2012. http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126833.pdf.
    • Guidance for industry: food-effect bioavailability and fed bioequivalence studies
  • 16
    • 84872614667 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Accessed April 16, 2012
    • Draft guidance on oxycodone hydrochloride US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Accessed April 16, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194657.pdf.
    • Draft guidance on oxycodone hydrochloride
  • 17
    • 0000722192 scopus 로고
    • Noncompartmental Analysis Based on Statistical Moment Theory
    • Marcel Dekker, Inc, New York, NY
    • Gibaldi M., Perrier D. Noncompartmental Analysis Based on Statistical Moment Theory. Pharmacokinetics 1982, 409. Marcel Dekker, Inc, New York, NY. 2nd ed.
    • (1982) Pharmacokinetics , pp. 409
    • Gibaldi, M.1    Perrier, D.2
  • 19
    • 0003922013 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md, Accessed April 16, 2012
    • Guidance for industry: statistical approaches to establishing bioequivalence January 2001, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md, Accessed April 16, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070244.pdf.
    • (2001) Guidance for industry: statistical approaches to establishing bioequivalence
  • 20
    • 0003455042 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md, Accessed April 16, 2012
    • Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations March 2003, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md, Accessed April 16, 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
    • (2003) Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations
  • 22
    • 0033634992 scopus 로고    scopus 로고
    • Confidence interval criteria for assessment of dose proportionality
    • Smith B.P., Vandenhende F.R., DeSante K.A., et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res 2000, 17:1278-1283.
    • (2000) Pharm Res , vol.17 , pp. 1278-1283
    • Smith, B.P.1    Vandenhende, F.R.2    DeSante, K.A.3
  • 23
    • 65649128074 scopus 로고    scopus 로고
    • Exploratory assessment of dose proportionality: review of current approaches and proposal for a practical criterion
    • Hummel J., McKendrick S., Brindley C., French R. Exploratory assessment of dose proportionality: review of current approaches and proposal for a practical criterion. Pharm Stat 2009, 8:38-49.
    • (2009) Pharm Stat , vol.8 , pp. 38-49
    • Hummel, J.1    McKendrick, S.2    Brindley, C.3    French, R.4
  • 24
    • 0029865429 scopus 로고    scopus 로고
    • Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution
    • Benziger D.P., Kaiko R.F., Miotto J.B., et al. Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution. J Pharm Sci 1996, 85:407-410.
    • (1996) J Pharm Sci , vol.85 , pp. 407-410
    • Benziger, D.P.1    Kaiko, R.F.2    Miotto, J.B.3
  • 25
    • 84872614463 scopus 로고    scopus 로고
    • Xanodyne Pharmaceuticals, Inc, Newport, KY, Accessed April 6, 2012
    • Roxicodone [prescribing information] 2009, Xanodyne Pharmaceuticals, Inc, Newport, KY, Accessed April 6, 2012. http://www.xanodyne.com/pdf/Roxicodone-5mg20mg-orals-tablet.pdf.
    • (2009) Roxicodone [prescribing information]
  • 26
    • 0029958271 scopus 로고    scopus 로고
    • A risk-benefit assessment of naltrexone in the treatment of alcohol dependence
    • Berg B.J., Pettinati H.M., Volpicelli J.R. A risk-benefit assessment of naltrexone in the treatment of alcohol dependence. Drug Saf 1996, 15:274-282.
    • (1996) Drug Saf , vol.15 , pp. 274-282
    • Berg, B.J.1    Pettinati, H.M.2    Volpicelli, J.R.3
  • 27
    • 77955605212 scopus 로고    scopus 로고
    • Efficacy and tolerability of naltrexone in the management of alcohol dependence
    • Garbutt J.C. Efficacy and tolerability of naltrexone in the management of alcohol dependence. Curr Pharm Des 2010, 16:2091-2097.
    • (2010) Curr Pharm Des , vol.16 , pp. 2091-2097
    • Garbutt, J.C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.