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Volumn 31, Issue 10, 2009, Pages 2242-2248

Bioequivalence of a single 10-mg dose of finasteride 5-mg oral disintegrating tablets and standard tablets in healthy adult male Han Chinese volunteers: A randomized sequence, open-label, two-way crossover study

Author keywords

bioavailability; bioequivalence; finasteride; human; pharmacokinetics

Indexed keywords

FINASTERIDE;

EID: 71549157424     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2009.09.015     Document Type: Article
Times cited : (11)

References (20)
  • 1
    • 0006075228 scopus 로고    scopus 로고
    • The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia
    • Finasteride Long-Term Efficacy and Safety Study Group
    • McConnell J.D., Bruskewitz R., Walsh P., et al., Finasteride Long-Term Efficacy and Safety Study Group. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Engl J Med. 338 (1998) 557-563
    • (1998) N Engl J Med. , vol.338 , pp. 557-563
    • McConnell, J.D.1    Bruskewitz, R.2    Walsh, P.3
  • 2
    • 0031683562 scopus 로고    scopus 로고
    • Finasteride in the treatment of men with androgenetic alopecia
    • Finasteride Male Pattern Hair Loss Study Group
    • Kaufman K.D., Olsen E.A., Whiting D., et al., Finasteride Male Pattern Hair Loss Study Group. Finasteride in the treatment of men with androgenetic alopecia. J Am Acad Dermatol. 39 (1998) 578-589
    • (1998) J Am Acad Dermatol. , vol.39 , pp. 578-589
    • Kaufman, K.D.1    Olsen, E.A.2    Whiting, D.3
  • 3
    • 17644367455 scopus 로고    scopus 로고
    • Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers
    • Almeida A., Almeida S., Filipe A., et al. Bioequivalence study of two different coated tablet formulations of finasteride in healthy volunteers. Arzneimittelforschung 55 (2005) 218-222
    • (2005) Arzneimittelforschung , vol.55 , pp. 218-222
    • Almeida, A.1    Almeida, S.2    Filipe, A.3
  • 4
    • 0035110444 scopus 로고    scopus 로고
    • Bioequivalence study of finasteride. Determination in human plasma by high-pressure liquid chromatography coupled to tandem mass spectrometry
    • de Menezes F.G., Ribeiro W., Ifa D.R., et al. Bioequivalence study of finasteride. Determination in human plasma by high-pressure liquid chromatography coupled to tandem mass spectrometry. Arzneimittelforschung 51 (2001) 145-150
    • (2001) Arzneimittelforschung , vol.51 , pp. 145-150
    • de Menezes, F.G.1    Ribeiro, W.2    Ifa, D.R.3
  • 5
    • 0030040505 scopus 로고    scopus 로고
    • Clinical pharmacokinetics and pharmacodynamics of finasteride
    • Steiner J.F. Clinical pharmacokinetics and pharmacodynamics of finasteride. Clin Pharmacokinet 30 (1996) 16-27
    • (1996) Clin Pharmacokinet , vol.30 , pp. 16-27
    • Steiner, J.F.1
  • 6
    • 0026612464 scopus 로고
    • Disposition and pharmacokinetics of [14C]finasteride after oral administration in humans
    • Carlin J.R., Höglund P., Eriksson L.O., et al. Disposition and pharmacokinetics of [14C]finasteride after oral administration in humans. Drug Metab Dispos. 20 (1992) 148-155
    • (1992) Drug Metab Dispos. , vol.20 , pp. 148-155
    • Carlin, J.R.1    Höglund, P.2    Eriksson, L.O.3
  • 7
    • 0031761149 scopus 로고    scopus 로고
    • Population-based studies of the epidemiology of benign prostatic hyperplasia
    • Girman C.J. Population-based studies of the epidemiology of benign prostatic hyperplasia. Br J Urol. 82 Suppl 1 (1998) 34-43
    • (1998) Br J Urol. , vol.82 , Issue.SUPPL. 1 , pp. 34-43
    • Girman, C.J.1
  • 8
    • 71549136563 scopus 로고    scopus 로고
    • Accessed September 22, 2009
    • Proscar (finasteride) [prescribing information]. http://www.propecia.com/finasteride/propecia/consumer/product-information/pi/ Accessed September 22, 2009
    • Proscar (finasteride) [prescribing information]
  • 9
    • 58049198455 scopus 로고    scopus 로고
    • Orally disintegrating systems: Innovations in formulation and technology
    • Goel H., Rai P., Rana V., and Tiwary A.K. Orally disintegrating systems: Innovations in formulation and technology. Recent Pat Drug Deliv Formul 2 (2008) 258-274
    • (2008) Recent Pat Drug Deliv Formul , vol.2 , pp. 258-274
    • Goel, H.1    Rai, P.2    Rana, V.3    Tiwary, A.K.4
  • 11
    • 71549126891 scopus 로고    scopus 로고
    • Accessed September 11, 2009
    • IV sets/syringes & needles. http://www.watkinssurgical.com/images/06_IVSyringes.pdf Accessed September 11, 2009
    • IV sets/syringes & needles
  • 12
    • 71549165848 scopus 로고    scopus 로고
    • Determination of finasteride in human plasma by HPLC-MS
    • Lan K., Jiang X., Ren J., et al. Determination of finasteride in human plasma by HPLC-MS. Asian J Pharmacodynam Pharmacokinet 6 (2006) 196-202
    • (2006) Asian J Pharmacodynam Pharmacokinet , vol.6 , pp. 196-202
    • Lan, K.1    Jiang, X.2    Ren, J.3
  • 14
    • 0000488030 scopus 로고
    • In vivo bioequivalence guidances
    • US Food and Drug Administration
    • US Food and Drug Administration. In vivo bioequivalence guidances. Pharmacopeial Forum 19 (1993) 6501-6508
    • (1993) Pharmacopeial Forum , vol.19 , pp. 6501-6508
  • 15
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann D.J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 15 (1987) 657-680
    • (1987) J Pharmacokinet Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 16
    • 71549170891 scopus 로고    scopus 로고
    • Accessed September 18, 2009
    • Propecia (finasteride) 1 mg [package insert]. http://www.merck.com/product/usa/pi_circulars/p/propecia/propecia_pi.pdf Accessed September 18, 2009
    • Propecia (finasteride) 1 mg [package insert]
  • 17
    • 0028824848 scopus 로고
    • Identification of human cytochrome P450 isozymes responsible for the in vitro oxidative metabolism of finasteride [published correction appears in Drug Metab Dispos. 1996;24695]
    • Huskey S.W., Dean D.C., Miller R.R., et al. Identification of human cytochrome P450 isozymes responsible for the in vitro oxidative metabolism of finasteride [published correction appears in Drug Metab Dispos. 1996;24695]. Drug Metab Dispos. 23 (1995) 1126-1135
    • (1995) Drug Metab Dispos. , vol.23 , pp. 1126-1135
    • Huskey, S.W.1    Dean, D.C.2    Miller, R.R.3
  • 18
    • 33750482920 scopus 로고    scopus 로고
    • Finasteride 1 mg has no inhibitory effect on omeprazole metabolism in extensive and poor metabolizers for CYP2C19 in Japanese
    • Yasumori T., Narita H., Matsuda T., et al. Finasteride 1 mg has no inhibitory effect on omeprazole metabolism in extensive and poor metabolizers for CYP2C19 in Japanese. Eur J Clin Pharmacol. 62 (2006) 939-946
    • (2006) Eur J Clin Pharmacol. , vol.62 , pp. 939-946
    • Yasumori, T.1    Narita, H.2    Matsuda, T.3
  • 19
    • 0033828454 scopus 로고    scopus 로고
    • The CYP2C19 enzyme polymorphism
    • Wedlund P.J. The CYP2C19 enzyme polymorphism. Pharmacology 61 (2000) 174-183
    • (2000) Pharmacology , vol.61 , pp. 174-183
    • Wedlund, P.J.1
  • 20
    • 8244249473 scopus 로고    scopus 로고
    • Differences in the incidence of the CYP2C19 polymorphism affecting the S-mephenytoin phenotype in Chinese Han and Bai populations and identification of a new rare CYP2C19 mutant allele
    • Xiao Z.S., Goldstein J.A., Xie H.G., et al. Differences in the incidence of the CYP2C19 polymorphism affecting the S-mephenytoin phenotype in Chinese Han and Bai populations and identification of a new rare CYP2C19 mutant allele. J Pharmacol Exp Ther. 281 (1997) 604-609
    • (1997) J Pharmacol Exp Ther. , vol.281 , pp. 604-609
    • Xiao, Z.S.1    Goldstein, J.A.2    Xie, H.G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.