메뉴 건너뛰기




Volumn 52, Issue 4, 2012, Pages 520-529

Thorough QT/QTc study of ritonavir-boosted saquinavir following multiple-dose administration of therapeutic and supratherapeutic doses in healthy participants

Author keywords

electrocardiography; moxifloxacin; ritonavir; Saquinavir; thorough QT QTc study

Indexed keywords

MOXIFLOXACIN; PLACEBO; RITONAVIR PLUS SAQUINAVIR;

EID: 84859089058     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011400071     Document Type: Article
Times cited : (25)

References (15)
  • 1
    • 84859076183 scopus 로고    scopus 로고
    • Nutley, NJ: Roche Laboratories; Accessed November 13, 2010
    • Invirase (saquinavir meyslate) capsules [package insert]. Nutley, NJ: Roche Laboratories; 2007. http://www.accessdata.fda.gov/drugsatfda-docs/label/ 2010/020628s033,021785s010lbl.pdf. Accessed November 13, 2010.
    • (2007) Invirase (Saquinavir Meyslate) Capsules [Package Insert]
  • 3
    • 37549043173 scopus 로고    scopus 로고
    • Ritonavir 100 mgdoes not cause QTc prolongation in healthy subjects: A possible role as CYP3A inhibitor in thorough QTc studies
    • Sarapa N, Nickens DJ, Raber SR, Reynolds RR, Amantea MA. Ritonavir 100 mgdoes not cause QTc prolongation in healthy subjects: a possible role as CYP3A inhibitor in thorough QTc studies. Clin Pharmacol Ther. 2008;83:153-159.
    • (2008) Clin Pharmacol Ther , vol.83 , pp. 153-159
    • Sarapa, N.1    Nickens, D.J.2    Raber, S.R.3    Reynolds, R.R.4    Amantea, M.A.5
  • 4
    • 27244456179 scopus 로고    scopus 로고
    • International Conference onHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH E14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
    • International Conference onHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Fed Register. 2005;70:61134-61135.
    • (2005) Fed Register , vol.70 , pp. 61134-61135
  • 5
    • 84859065220 scopus 로고    scopus 로고
    • A randomized, double-blind, positive-controlled, 14-day multiple ascending dose study to investigate the safety, tolerability, and pharmacokinetics of saquinavir boosted with ritonavir in healthy subjects
    • Abstract PIII-71
    • Lee LS, Backholer Z, Zandt H, Kolis S, Salgo M, Zhang X. A randomized, double-blind, positive-controlled, 14-day multiple ascending dose study to investigate the safety, tolerability, and pharmacokinetics of saquinavir boosted with ritonavir in healthy subjects. Clin Pharmacol Ther. 2009;85(suppl):S90. Abstract PIII-71.
    • (2009) Clin Pharmacol Ther , vol.85 , Issue.SUPPL.
    • Lee, L.S.1    Backholer, Z.2    Zandt, H.3    Kolis, S.4    Salgo, M.5    Zhang, X.6
  • 6
    • 84856307711 scopus 로고    scopus 로고
    • National Cancer Institute Version 3. October Accessed August 9, 2010
    • National Cancer Institute Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC). Version 3. October 2006. http:// ctep.cancer.gov/protocolDevelopment/ electronic-applications/ctc.htm#ctc-30. Accessed August 9, 2010.
    • (2006) Common Terminology Criteria for Adverse Events (CTCAE) and Common Toxicity Criteria (CTC)
  • 7
    • 0001127258 scopus 로고
    • An analysis of the time relationship to the electrocardiogram
    • Bazett H. An analysis of the time relationship to the electrocardiogram. Heart. 1920;7:353-367.
    • (1920) Heart , vol.7 , pp. 353-367
    • Bazett, H.1
  • 8
    • 84980098899 scopus 로고
    • Die systolen dauer imelektrokardiogramm bei normalen menschen und bei herzkranke
    • Fridericia L. Die systolen dauer imelektrokardiogramm bei normalen menschen und bei herzkranke. Acta Med Scand. 1920;53:469-486.
    • (1920) Acta Med Scand , vol.53 , pp. 469-486
    • Fridericia, L.1
  • 9
    • 65449138704 scopus 로고    scopus 로고
    • Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested
    • Zhang X, Silkey M, Schumacher M, Wang L, Raval H, Caulfield JP. Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested. J Clin Pharmacol. 2009;49:534-539.
    • (2009) J Clin Pharmacol , vol.49 , pp. 534-539
    • Zhang, X.1    Silkey, M.2    Schumacher, M.3    Wang, L.4    Raval, H.5    Caulfield, J.P.6
  • 10
    • 12344307070 scopus 로고    scopus 로고
    • Drug-induced QT dispersion: Does it predict the risk of torsade de pointes?
    • DOI 10.1016/j.jelectrocard.2004.09.001, PII S0022073604001505
    • Shah RR. Drug-induced QTdispersion: does it predict the risk of torsade de pointes? J Electrocardiol. 2005;38(1):10-18. (Pubitemid 40127171)
    • (2005) Journal of Electrocardiology , vol.38 , Issue.1 , pp. 10-18
    • Shah, R.R.1
  • 15
    • 0037648770 scopus 로고    scopus 로고
    • Pharmacokinetic and tolerability profile of twice-daily saquinavir hard gelatin capsules and saquinavir soft gelatin capsules boosted with ritonavir in healthy volunteers
    • DOI 10.1046/j.1468-1293.2003.00143.x
    • Kurowski M, Sternfeld T, Sawyer A, Hill A, Möcklinghoff C. Pharmacokinetic and tolerability profile of twice-daily saquinavir hard gelatin capsules and saquinavir soft gelatin capsules boosted with ritonavir in healthy volunteers. HIV Med. 2003;4:94-100. (Pubitemid 36582291)
    • (2003) HIV Medicine , vol.4 , Issue.2 , pp. 94-100
    • Kurowski, M.1    Sternfeld, T.2    Sawyer, A.3    Hill, A.4    Mocklinghoff, C.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.