메뉴 건너뛰기




Volumn 68, Issue 12, 2012, Pages 1595-1603

Pharmacokinetics and pharmacodynamics of single-dose oral tolvaptan in fasted and non-fasted states in healthy Caucasian and Japanese male subjects

Author keywords

Bridging; Food effect; Pharmacodynamics; Pharmacokinetics; Tolvaptan

Indexed keywords

TOLVAPTAN;

EID: 84871306932     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-012-1295-5     Document Type: Article
Times cited : (27)

References (18)
  • 1
    • 49949090275 scopus 로고    scopus 로고
    • The role of ethnicity in variability in response to drugs: Focus on clinical pharmacology studies
    • doi:10.1038/ clpt.2008.141
    • Yasuda SU, Zhang L, Huang SM (2008) The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther 84(3):417-423. doi:10.1038/ clpt.2008.141
    • (2008) Clin Pharmacol Ther , vol.84 , Issue.3 , pp. 417-423
    • Yasuda, S.U.1    Zhang, L.2    Huang, S.M.3
  • 2
    • 79960708081 scopus 로고    scopus 로고
    • Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan
    • doi:10.1177/0091270010381500
    • Fukunaga S, Kusama M, Arnold FL, Ono S (2011) Ethnic differences in pharmacokinetics in new drug applications and approved doses in Japan. J Clin Pharmacol 51(8):1237-1240. doi:10.1177/0091270010381500
    • (2011) J Clin Pharmacol , vol.51 , Issue.8 , pp. 1237-1240
    • Fukunaga, S.1    Kusama, M.2    Arnold, F.L.3    Ono, S.4
  • 3
    • 4444268163 scopus 로고    scopus 로고
    • Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms
    • doi:10.1177/0091270004268128
    • Kim K, Johnson JA, Derendorf H (2004) Differences in drug pharmacokinetics between East Asians and Caucasians and the role of genetic polymorphisms. J Clin Pharmacol 44(10):1083- 1105. doi:10.1177/0091270004268128
    • (2004) J Clin Pharmacol , vol.44 , Issue.10 , pp. 1083-1105
    • Kim, K.1    Johnson, J.A.2    Derendorf, H.3
  • 4
    • 0033950015 scopus 로고    scopus 로고
    • Predictability of the effects of race or ethnicity on pharmacokinetics of drugs
    • Johnson JA (2000) Predictability of the effects of race or ethnicity on pharmacokinetics of drugs. Int J Clin Pharmacol Ther 38(2):53- 60
    • (2000) Int J Clin Pharmacol Ther , vol.38 , Issue.2 , pp. 53-60
    • Johnson, J.A.1
  • 5
    • 33748951017 scopus 로고    scopus 로고
    • Ethnic or racial differences revisited: Impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics
    • Chen ML (2006) Ethnic or racial differences revisited: impact of dosage regimen and dosage form on pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 45(10):957-964
    • (2006) Clin Pharmacokinet , vol.45 , Issue.10 , pp. 957-964
    • Chen, M.L.1
  • 6
    • 23444432195 scopus 로고    scopus 로고
    • Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan
    • doi:10.1016/j.clpt.2005.04.001
    • Uyama Y, Shibata T, Nagai N, Hanaoka H, Toyoshima S, Mori K (2005) Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther 78(2):102-113. doi:10.1016/j.clpt.2005.04.001
    • (2005) Clin Pharmacol Ther , vol.78 , Issue.2 , pp. 102-113
    • Uyama, Y.1    Shibata, T.2    Nagai, N.3    Hanaoka, H.4    Toyoshima, S.5    Mori, K.6
  • 7
    • 77149143531 scopus 로고    scopus 로고
    • Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors
    • doi:10.1038/clpt.2009.285
    • Ichimaru K, Toyoshima S, Uyama Y (2010) Effective global drug development strategy for obtaining regulatory approval in Japan in the context of ethnicity-related drug response factors. Clin Pharmacol Ther 87(3):362-366. doi:10.1038/clpt.2009.285
    • (2010) Clin Pharmacol Ther , vol.87 , Issue.3 , pp. 362-366
    • Ichimaru, K.1    Toyoshima, S.2    Uyama, Y.3
  • 8
    • 34249037098 scopus 로고    scopus 로고
    • Predicting effect of food on extent of drug absorption based on physicochemical properties
    • doi:10.1007/s11095-007-9236-1
    • Gu CH, Li H, Levons J, Lentz K, Gandhi RB, Raghavan K, Smith RL (2007) Predicting effect of food on extent of drug absorption based on physicochemical properties. Pharm Res 24(6):1118- 1130. doi:10.1007/s11095-007-9236-1
    • (2007) Pharm Res , vol.24 , Issue.6 , pp. 1118-1130
    • Gu, C.H.1    Li, H.2    Levons, J.3    Lentz, K.4    Gandhi, R.B.5    Raghavan, K.6    Smith, R.L.7
  • 10
    • 0029942399 scopus 로고    scopus 로고
    • Pathophysiology of the aquaporin water channels
    • doi:10.1146/ annurev.ph.58.030196.003155
    • King LS, Agre P (1996) Pathophysiology of the aquaporin water channels. Annu Rev Physiol 58:619-648. doi:10.1146/ annurev.ph.58.030196.003155
    • (1996) Annu Rev Physiol , vol.58 , pp. 619-648
    • King, L.S.1    Agre, P.2
  • 11
    • 36148983374 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics, and safety of tolvaptan, a nonpeptide AVP antagonist, during ascending single-dose studies in healthy subjects
    • doi:10.1177/091270007307877
    • Shoaf SE, Wang Z, Bricmont P, Mallikaarjun S (2007) Pharmacokinetics, pharmacodynamics, and safety of tolvaptan, a nonpeptide AVP antagonist, during ascending single-dose studies in healthy subjects. J Clin Pharmacol 47(12):1498-1507. doi:10.1177/ 0091270007307877
    • (2007) J Clin Pharmacol , vol.47 , Issue.12 , pp. 1498-1507
    • Shoaf, S.E.1    Wang, Z.2    Bricmont, P.3    Mallikaarjun, S.4
  • 12
    • 0030961906 scopus 로고    scopus 로고
    • Hyponatremia and hypernatremia
    • Fried LF, Palevsky PM (1997) Hyponatremia and hypernatremia. Med Clin North Am 81(3):585-609
    • (1997) Med Clin North Am , vol.81 , Issue.3 , pp. 585-609
    • Fried, L.F.1    Palevsky, P.M.2
  • 13
    • 0242350785 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). CDER, Silver Spring
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) (2002) Guidance for industry: food-effect bioavailability and fed bioequivalence studies. CDER, Silver Spring, pp 1-12
    • (2002) Guidance for Industry: Food-effect Bioavailability and Fed Bioequivalence Studies , pp. 1-12
  • 15
    • 0003024589 scopus 로고
    • Guidelines for collection and analysis of pharmacokinetic data
    • Evans WE, Jusko WJ, Schentag JJ (eds) Lippincott Williams & Wilkins, Philadelphia
    • Jusko WJ (1992) Guidelines for collection and analysis of pharmacokinetic data. In: Evans WE, Jusko WJ, Schentag JJ (eds) Applied pharmacokinetics: principles of therapeutic drug monitoring, 3rd edn. Lippincott Williams & Wilkins, Philadelphia, p 1202
    • (1992) Applied Pharmacokinetics: Principles of Therapeutic Drug Monitoring, 3rd Edn. , pp. 1202
    • Jusko, W.J.1
  • 17
    • 84862280664 scopus 로고    scopus 로고
    • Highly variable drugs: Bioequivalence requirement and regulatory perspectives
    • Dangi YS, Soni ML, Namdeo KP (2010) Highly variable drugs: Bioequivalence requirement and regulatory perspectives. J Curr Pharm Res 3:24-8
    • (2010) J Curr Pharm Res , vol.3 , pp. 24-28
    • Dangi, Y.S.1    Soni, M.L.2    Namdeo, K.P.3
  • 18
    • 33751005260 scopus 로고    scopus 로고
    • Tolvaptan, a selective oral vasopressin V2- receptor antagonist, for hyponatremia
    • doi:10.1056/NEJMoa065181
    • Schrier RW, Gross P, Gheorghiade M, Berl T, Verbalis JG, Czerwiec FS, Orlandi C (2006) Tolvaptan, a selective oral vasopressin V2- receptor antagonist, for hyponatremia. N Engl J Med 355(20):2099- 2112. doi:10.1056/NEJMoa065181
    • (2006) N Engl J Med , vol.355 , Issue.20 , pp. 2099-2112
    • Schrier, R.W.1    Gross, P.2    Gheorghiade, M.3    Berl, T.4    Verbalis, J.G.5    Czerwiec, F.S.6    Orlandi, C.7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.