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Volumn 58, Issue 7, 2008, Pages 323-327

Comparative pharmacokinetics of a single oral dose of two formulations of amlodipine: A randomized, single-blind, two-period, two-sequence, crossover study

Author keywords

Amlodipine besylate, bioequivalence, pharmacokinetics; Calcium channel antagonists, dihydropyridine; CAS 111470 99 6

Indexed keywords

AMLODIPINE BESYLATE; PELMEC;

EID: 49449099930     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1296514     Document Type: Article
Times cited : (3)

References (20)
  • 1
    • 0026012842 scopus 로고
    • Amlodipine - A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in cardiovascular disease
    • Murdoch D, Heel RC. Amlodipine - A review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in cardiovascular disease. Drugs. 1991;41 (3):478-505.
    • (1991) Drugs , vol.41 , Issue.3 , pp. 478-505
    • Murdoch, D.1    Heel, R.C.2
  • 2
    • 0028302036 scopus 로고
    • Vascular versus myocardial effects of calcium antagonists
    • Little WC, Cheng CP. Vascular versus myocardial effects of calcium antagonists. Drugs. 1994;47 (Suppl 4):41-45.
    • (1994) Drugs , vol.47 , Issue.SUPPL. 4 , pp. 41-45
    • Little, W.C.1    Cheng, C.P.2
  • 3
    • 0023026272 scopus 로고
    • The pharmacokinetics of amlodipine in healthy volunteers after intravenous, and oral doses and after 14 repeated oral doses once daily
    • Faulkner JK, DmcGibney D, Chasseaud LF, Perry JL, Taylor IW. The pharmacokinetics of amlodipine in healthy volunteers after intravenous, and oral doses and after 14 repeated oral doses once daily. Br J Clin Pharmacol. 1986;22: 21-25.
    • (1986) Br J Clin Pharmacol , vol.22 , pp. 21-25
    • Faulkner, J.K.1    DmcGibney, D.2    Chasseaud, L.F.3    Perry, J.L.4    Taylor, I.W.5
  • 4
    • 0026584793 scopus 로고
    • Clinical pharmacokinetics of amlodipine
    • Meredithy PA, Elliott HL. Clinical pharmacokinetics of amlodipine. Clin Pharmacokinet. 1992;22(1):22-31.
    • (1992) Clin Pharmacokinet , vol.22 , Issue.1 , pp. 22-31
    • Meredithy, P.A.1    Elliott, H.L.2
  • 5
    • 0024428673 scopus 로고
    • The safety of amlodipine
    • Osterloh I. The safety of amlodipine. Am Heart J. 1989;118: 1114-1120.
    • (1989) Am Heart J , vol.118 , pp. 1114-1120
    • Osterloh, I.1
  • 6
    • 0033731288 scopus 로고    scopus 로고
    • Pharmacokinetics of Repeated Oral Doses of Amlodipine plus Telmisartan in Healthy Volunteers
    • Stangier J, Su C. Pharmacokinetics of Repeated Oral Doses of Amlodipine plus Telmisartan in Healthy Volunteers. J Clin Pharmacol. 2000;40:1347-1354.
    • (2000) J Clin Pharmacol , vol.40 , pp. 1347-1354
    • Stangier, J.1    Su, C.2
  • 8
    • 0035879909 scopus 로고    scopus 로고
    • Determination of amlodipine in human plasma by high-performance liquid chromatography with fluorescence detection
    • Tatar S, Atmaca S. Determination of amlodipine in human plasma by high-performance liquid chromatography with fluorescence detection. J Chromatogr B Biomed Sci Appl. 2001;758(2):305-310.
    • (2001) J Chromatogr B Biomed Sci Appl , vol.758 , Issue.2 , pp. 305-310
    • Tatar, S.1    Atmaca, S.2
  • 9
    • 4444377529 scopus 로고    scopus 로고
    • Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies
    • Bahrami G, Mirzaeei S. Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies. J Pharm Biomed Anal. 2004;36(1):163-168.
    • (2004) J Pharm Biomed Anal , vol.36 , Issue.1 , pp. 163-168
    • Bahrami, G.1    Mirzaeei, S.2
  • 11
    • 49449084698 scopus 로고    scopus 로고
    • Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401/98 26 July 2001.
    • Note for Guidance on the Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401/98 26 July 2001.
  • 12
    • 49449105685 scopus 로고    scopus 로고
    • Food and Drug Administration. Bioavalilability and bioequivalence requirements. CFR Title 21, 5 Parts 300/0499. Revised April 1, 2001
    • Food and Drug Administration. Bioavalilability and bioequivalence requirements. CFR Title 21, Volume 5 Parts 300/0499. Revised April 1, 2001.
  • 13
    • 49449098208 scopus 로고    scopus 로고
    • Center of Drug Evaluation and Research. Guidance for Industry
    • Food and Drug Administration, Revised January
    • Food and Drug Administration. Center of Drug Evaluation and Research. Guidance for Industry. Statistical approaches to establishing bioequivalence. Revised January 2001.
    • (2001) Statistical approaches to establishing bioequivalence
  • 14
    • 0023615056 scopus 로고
    • Comparison of the two one-sided procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DA. Comparison of the two one-sided procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15 (6):657-680.
    • (1987) J Pharmacokinet Biopharm , vol.15 , Issue.6 , pp. 657-680
    • Schuirmann, D.A.1
  • 15
    • 0021271539 scopus 로고
    • A new statistical procedure for testing equivalence in two-group comparative bioavailability trials
    • Hauck WW, Anderson SJ. A new statistical procedure for testing equivalence in two-group comparative bioavailability trials. Pharmacokinetic Biopharm. 1984;12:83-91.
    • (1984) Pharmacokinetic Biopharm , vol.12 , pp. 83-91
    • Hauck, W.W.1    Anderson, S.J.2
  • 16
    • 49449109524 scopus 로고
    • Design analysis
    • Chow S, Liu JP editors, New York: Marcel Decker;
    • Chow S, Liu JP editors. Design analysis: Bioavailability and bioequivalence studies. New York: Marcel Decker; 1982.
    • (1982) Bioavailability and bioequivalence studies
  • 17
    • 49449089952 scopus 로고    scopus 로고
    • Food and Drug Administration Guidance. Statistical procedure for bioequivalence studies using standard 2-treatment cross-over design: Statement under 21 CFR 10.9. Rockville, MD: US Department of Health and Human Services; 1992.
    • Food and Drug Administration Guidance. Statistical procedure for bioequivalence studies using standard 2-treatment cross-over design: Statement under 21 CFR 10.9. Rockville, MD: US Department of Health and Human Services; 1992.
  • 18
    • 0022897897 scopus 로고    scopus 로고
    • Shumaker RC PKCALC: a BASIC interactive computer program for statistical and pharmacokinetic analysis of data. Drug Metab Rev. 1986;7(3-4):331-348.
    • Shumaker RC PKCALC: a BASIC interactive computer program for statistical and pharmacokinetic analysis of data. Drug Metab Rev. 1986;7(3-4):331-348.
  • 19
    • 0028948839 scopus 로고
    • A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability
    • Amidon GL, Lennernas H , Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413-420.
    • (1995) Pharm Res , vol.12 , pp. 413-420
    • Amidon, G.L.1    Lennernas, H.2    Shah, V.P.3    Crison, J.R.4
  • 20
    • 14644406250 scopus 로고    scopus 로고
    • Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study
    • Abad-Santos F, Novalbos J, Gálvez-Múgica MA, Gallego-Sandín S, Almeida S, Valleé F, et al. Assessment of sex differences in pharmacokinetics and pharmacodynamics of amlodipine in a bioequivalence study. Pharmacol Res. 2005; 51(5):445-52.
    • (2005) Pharmacol Res , vol.51 , Issue.5 , pp. 445-452
    • Abad-Santos, F.1    Novalbos, J.2    Gálvez-Múgica, M.A.3    Gallego-Sandín, S.4    Almeida, S.5    Valleé, F.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.