메뉴 건너뛰기




Volumn 9, Issue 4, 2013, Pages 291-300

Pharmacokinetic evaluation of tapentadol extended-release tablets in healthy subjects

Author keywords

Extended release; Pharmacokinetics; Tapentadol

Indexed keywords

DRUG METABOLITE; HYDROXYPROPYLMETHYLCELLULOSE; MACROGOL; POLYETHYLENE; TAPENTADOL; TAPENTADOL O GLUCURONIDE; UNCLASSIFIED DRUG;

EID: 84886659116     PISSN: 15517489     EISSN: None     Source Type: Journal    
DOI: 10.5055/jom.2013.0171     Document Type: Article
Times cited : (15)

References (24)
  • 2
    • 33847027978 scopus 로고    scopus 로고
    • Tapentadol hydrochloride. Analgesic, mu-opioid receptor agonist, noradrenaline reuptake inhibitor
    • Tzschentke TM, De Vry J, Terlinden R, et al.: Tapentadol hydrochloride. Analgesic, mu-opioid receptor agonist, noradrenaline reuptake inhibitor. Drugs Future. 2006; 31(12): 1053-1061.
    • (2006) Drugs Future , vol.31 , Issue.12 , pp. 1053-1061
    • Tzschentke, T.M.1    De Vry, J.2    Terlinden, R.3
  • 3
    • 62149094353 scopus 로고    scopus 로고
    • Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: A 10-day, phase III, randomized, double-blind, active- and placebo-controlled study
    • Hartrick C, Van Hove I, Stegmann J-U, et al.: Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: A 10-day, phase III, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2009; 31(2): 260-271.
    • (2009) Clin Ther , vol.31 , Issue.2 , pp. 260-271
    • Hartrick, C.1    Van Hove, I.2    Stegmann, J.-U.3
  • 4
    • 77954776260 scopus 로고    scopus 로고
    • Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study
    • Buynak R, Shapiro DY, Okamoto A, et al.: Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study. Expert Opin Pharmacother. 2010; 11(11): 1787-1804.
    • (2010) Expert Opin Pharmacother , vol.11 , Issue.11 , pp. 1787-1804
    • Buynak, R.1    Shapiro, D.Y.2    Okamoto, A.3
  • 5
    • 77954211482 scopus 로고    scopus 로고
    • Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo- and active-controlled phase III study
    • Afilalo M, Etropolski MS, Kuperwasser B, et al.: Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo- and active-controlled phase III study. Clin Drug Investig. 2010; 30(8): 489-505.
    • (2010) Clin Drug Investig , vol.30 , Issue.8 , pp. 489-505
    • Afilalo, M.1    Etropolski, M.S.2    Kuperwasser, B.3
  • 6
    • 76149100904 scopus 로고    scopus 로고
    • Dose conversion between tapentadol immediate and extended release for low back pain
    • Etropolski M, Okamoto A, Shapiro DY, et al.: Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician. 2010; 13(1): 61-70.
    • (2010) Pain Physician , vol.13 , Issue.1 , pp. 61-70
    • Etropolski, M.1    Okamoto, A.2    Shapiro, D.Y.3
  • 7
    • 77956231967 scopus 로고    scopus 로고
    • Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain
    • Lange B, Kuperwasser B, Okamoto A, et al.: Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv Ther. 2010; 27(6): 381-399.
    • (2010) Adv Ther , vol.27 , Issue.6 , pp. 381-399
    • Lange, B.1    Kuperwasser, B.2    Okamoto, A.3
  • 8
    • 78650394491 scopus 로고    scopus 로고
    • Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: Results of a randomized-withdrawal, placebo-controlled trial
    • Schwartz S, Etropolski M, Shapiro DY, et al.: Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: Results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011; 27(1): 151-162.
    • (2011) Curr Med Res Opin , vol.27 , Issue.1 , pp. 151-162
    • Schwartz, S.1    Etropolski, M.2    Shapiro, D.Y.3
  • 9
    • 77954810443 scopus 로고    scopus 로고
    • Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain
    • Wild JE, Grand S, Kuperwasser B, et al.: Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010; 10(5): 416-427.
    • (2010) Pain Pract , vol.10 , Issue.5 , pp. 416-427
    • Wild, J.E.1    Grand, S.2    Kuperwasser, B.3
  • 14
    • 0003478656 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products (ed.): London: The European Agency for the Evaluation of Medicinal Products
    • The European Agency for the Evaluation of Medicinal Products (ed.): Note for Guidance on the Investigation of Bioavailability and Bioequivalence. London: The European Agency for the Evaluation of Medicinal Products, 2001.
    • (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence
  • 16
    • 0003455042 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, et al. (eds.): Rockville, MD: Center for Drug Evaluation and Research
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, et al. (eds.): Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Rockville, MD: Center for Drug Evaluation and Research, 2003.
    • (2003) Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations
  • 17
    • 84884283925 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Center for Drug Evaluation and Research: Guidance for industry Available at Accessed October 27, 2011
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Guidance for industry: Food-effect bioavailability and fed bioequivalence studies. Available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833pdf. Accessed October 27, 2011.
    • Food-effect Bioavailability and Fed Bioequivalence Studies
  • 18
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, et al. (eds.): Rockville, MD: Center for Drug Evaluation and Research
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, et al. (eds.): Guidance for Industry: Bioanalytical Method Validation. Rockville, MD: Center for Drug Evaluation and Research, 2001.
    • (2001) Guidance for Industry: Bioanalytical Method Validation
  • 19
    • 75149147267 scopus 로고    scopus 로고
    • Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: Results of two randomized, open-label, crossover, drug-drug interaction studies
    • Smit JW, Oh C, Rengelshausen J, et al.: Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: Results of two randomized, open-label, crossover, drug-drug interaction studies. Pharmacotherapy. 2010; 30(1): 25-34.
    • (2010) Pharmacotherapy , vol.30 , Issue.1 , pp. 25-34
    • Smit, J.W.1    Oh, C.2    Rengelshausen, J.3
  • 20
    • 84874763051 scopus 로고    scopus 로고
    • Ortho-McNeil-Janssen Pharmaceuticals: Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
    • Ortho-McNeil-Janssen Pharmaceuticals: Nucynta® (tapentadol) immediate-release oral tablets [package insert]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc., 2011.
    • (2011) Nucynta® (Tapentadol) Immediate-release Oral Tablets [Package Insert]
  • 21
    • 40949135791 scopus 로고    scopus 로고
    • Investigations into the drug-drug interaction potential of tapentadol in human liver microsomes and fresh human hepatocytes
    • DOI 10.2174/187231208783478434
    • Kneip C, Terlinden R, Beier H, et al.: Investigations into the drug-drug interaction potential of tapentadol in human liver microsomes and fresh human hepatocytes. Drug Metab Lett. 2008; 2(1): 67-75. (Pubitemid 351411265)
    • (2008) Drug Metabolism Letters , vol.2 , Issue.1 , pp. 67-75
    • Kneip, C.1    Terlinden, R.2    Beier, H.3    Chen, G.4
  • 22
  • 23
    • 77956365463 scopus 로고    scopus 로고
    • Population pharmacokinetics of tapentadol immediate release (IR) in healthy subjects and patients with moderate or severe pain
    • Xu XS, Smit JW, Lin R, et al.: Population pharmacokinetics of tapentadol immediate release (IR) in healthy subjects and patients with moderate or severe pain. Clin Pharmacokinet. 2010; 49(10): 671-682.
    • (2010) Clin Pharmacokinet , vol.49 , Issue.10 , pp. 671-682
    • Xu, X.S.1    Smit, J.W.2    Lin, R.3
  • 24
    • 39149115065 scopus 로고    scopus 로고
    • Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption
    • Custodio JM, Wu CY, Benet LZ: Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption. Adv Drug Deliv Rev. 2008; 60(6): 717-733.
    • (2008) Adv Drug Deliv Rev , vol.60 , Issue.6 , pp. 717-733
    • Custodio, J.M.1    Wu, C.Y.2    Benet, L.Z.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.