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Volumn 29, Issue 8, 2007, Pages 539-552

Single-dose, randomized, crossover bioequivalence study of amlodipine maleate versus amlodipine besylate in healthy volunteers

Author keywords

Amlodipine; Besylate; Bioequivalence; Maleate; Sex differences

Indexed keywords

AMLODIPINE; AMLODIPINE BESYLATE; AMLODIPINE MALEATE; GENERIC DRUG; SODIUM CHLORIDE; UNCLASSIFIED DRUG;

EID: 36849033345     PISSN: 10641963     EISSN: 15256006     Source Type: Journal    
DOI: 10.1080/10641960701744046     Document Type: Article
Times cited : (14)

References (35)
  • 1
    • 0004122190 scopus 로고    scopus 로고
    • ed, St. Louis, Mo, Elsevier Science;, III-157
    • Nissen D, ed. Mosby's Drug Consult. St. Louis, Mo.: Elsevier Science; 2003: III-157.
    • (2003) Mosby's Drug Consult
  • 2
    • 36849036884 scopus 로고    scopus 로고
    • Hutchison TA, Shahan DR, eds. DRUGDEX System. Greenwood Village, Colorado: MICROMEDEX; 2003:115.
    • Hutchison TA, Shahan DR, eds. DRUGDEX System. Greenwood Village, Colorado: MICROMEDEX; 2003:115.
  • 3
    • 0028295970 scopus 로고
    • Unique pharmacologic properties of amlodipine
    • Burges R, Moisey D. Unique pharmacologic properties of amlodipine. Am J Cardiol. 1994;73:2A-9A.
    • (1994) Am J Cardiol , vol.73
    • Burges, R.1    Moisey, D.2
  • 4
    • 0037275186 scopus 로고    scopus 로고
    • Management of calcium antagonist overdose
    • Salhanick S, Shannon MW. Management of calcium antagonist overdose. Drug Safety. 2003;26:65-79.
    • (2003) Drug Safety , vol.26 , pp. 65-79
    • Salhanick, S.1    Shannon, M.W.2
  • 5
    • 0346753452 scopus 로고    scopus 로고
    • Novel vascular biology of third-generation L-type calcium channel antagonists: Ancillary actions of amlodipine
    • Mason RP, Marche P, Hintze TH. Novel vascular biology of third-generation L-type calcium channel antagonists: Ancillary actions of amlodipine. Arterioscler Thromb Vasc Biol. 2003;23:2155-2163.
    • (2003) Arterioscler Thromb Vasc Biol , vol.23 , pp. 2155-2163
    • Mason, R.P.1    Marche, P.2    Hintze, T.H.3
  • 6
    • 36849036883 scopus 로고    scopus 로고
    • EMEA/CPMC opinion following an article 29 referral. International non-proprietary name: Amlodipine. London; 2004.
    • EMEA/CPMC opinion following an article 29 referral. International non-proprietary name: Amlodipine. London; 2004.
  • 7
    • 19544390886 scopus 로고    scopus 로고
    • Results of a multicenter, eight-week, parallel-group, randomized, double-blind, double-dummy, Phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension
    • Park S, Chung N, Kwon J, Yoon JH, Kim YJ, Han DS, Kim HS. Results of a multicenter, eight-week, parallel-group, randomized, double-blind, double-dummy, Phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension. Clin Ther. 2005;27:441-450.
    • (2005) Clin Ther , vol.27 , pp. 441-450
    • Park, S.1    Chung, N.2    Kwon, J.3    Yoon, J.H.4    Kim, Y.J.5    Han, D.S.6    Kim, H.S.7
  • 8
    • 23044439528 scopus 로고    scopus 로고
    • New amlodipine (Amloc) product available in South Africa. Cardiovasc J S Afr. 2005;16:61.
    • New amlodipine (Amloc) product available in South Africa. Cardiovasc J S Afr. 2005;16:61.
  • 9
    • 2942604428 scopus 로고    scopus 로고
    • Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects
    • Park JY, Kim KA, Lee GS, Park PW, Kim SL, Lee YS, Lee YW, Shin EK. Randomized, open-label, two-period crossover comparison of the pharmacokinetic and pharmacodynamic properties of two amlodipine formulations in healthy adult male Korean subjects. Clin Ther. 2004;26:715-723.
    • (2004) Clin Ther , vol.26 , pp. 715-723
    • Park, J.Y.1    Kim, K.A.2    Lee, G.S.3    Park, P.W.4    Kim, S.L.5    Lee, Y.S.6    Lee, Y.W.7    Shin, E.K.8
  • 10
    • 33646869023 scopus 로고    scopus 로고
    • Comparison of efficacy and tolerability of amlodipine orotate versus amlodipine besylate in adult patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, eight-week follow-up, noninferiority trial
    • Hong SJ, Ahn TH, Baek SH, Cho WH, Jeon HK, Kyun J, Yoon MH, Lee KJ, Lim DS. Comparison of efficacy and tolerability of amlodipine orotate versus amlodipine besylate in adult patients with mild to moderate hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, eight-week follow-up, noninferiority trial. Clin Ther. 2006;28:537-551.
    • (2006) Clin Ther , vol.28 , pp. 537-551
    • Hong, S.J.1    Ahn, T.H.2    Baek, S.H.3    Cho, W.H.4    Jeon, H.K.5    Kyun, J.6    Yoon, M.H.7    Lee, K.J.8    Lim, D.S.9
  • 11
    • 36849032282 scopus 로고    scopus 로고
    • European Agency for the Evaluation of Medical Products, Committee for Proprietary Medical Products, July 17
    • European Agency for the Evaluation of Medical Products, Committee for Proprietary Medical Products. Good Clinical Practice: Consolidated Guideline CPMP/ICH/135/95. 1996 July 17.
    • (1996) Good Clinical Practice: Consolidated Guideline CPMP/ICH/135/95
  • 12
    • 36849035429 scopus 로고    scopus 로고
    • Recepimento delle linee guida dell'U.E. di Buona Pratica Clinica per la esecuzione delle sperimentazioni cliniche dei medicinali. Gazzetta Ufficiale della Repubblica Italiana; 1997 Jun 15:139.
    • Recepimento delle linee guida dell'U.E. di Buona Pratica Clinica per la esecuzione delle sperimentazioni cliniche dei medicinali. Gazzetta Ufficiale della Repubblica Italiana; 1997 Jun 15:139.
  • 13
    • 0023026272 scopus 로고
    • The pharmacokinetics of amlodipine in healthy volunteers after single intravenous and oral doses and after 14 repeated oral doses given once daily
    • Faulkner JK, McGibney D, Chasseaud LF, Perry JL, Taylor IW. The pharmacokinetics of amlodipine in healthy volunteers after single intravenous and oral doses and after 14 repeated oral doses given once daily. Br J Clin Pharmacol. 1986;22:21-25.
    • (1986) Br J Clin Pharmacol , vol.22 , pp. 21-25
    • Faulkner, J.K.1    McGibney, D.2    Chasseaud, L.F.3    Perry, J.L.4    Taylor, I.W.5
  • 15
    • 0015379868 scopus 로고
    • Use of confidence intervals in analysis of comparative bioavailability trials
    • Westlake W. Use of confidence intervals in analysis of comparative bioavailability trials. J Pharm Sci. 1972;6:1340-1341.
    • (1972) J Pharm Sci , vol.6 , pp. 1340-1341
    • Westlake, W.1
  • 16
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokin Biopharm. 1987;15:657-680.
    • (1987) J Pharmacokin Biopharm , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 17
    • 0025332058 scopus 로고
    • A distribution free procedure for the statistical analysis of bioequivalence studies
    • Hauschke D, Steinijans VW, Diletti E. A distribution free procedure for the statistical analysis of bioequivalence studies. Int J Clin Pharmacol Ther Toxicol. 1990;28:72-78.
    • (1990) Int J Clin Pharmacol Ther Toxicol , vol.28 , pp. 72-78
    • Hauschke, D.1    Steinijans, V.W.2    Diletti, E.3
  • 19
    • 0025334006 scopus 로고
    • Power of the two one-sided tests procedure in bioequivalence
    • Phillips KF. Power of the two one-sided tests procedure in bioequivalence. J Pharmacokinet Biopharm. 1990;18:137-144.
    • (1990) J Pharmacokinet Biopharm , vol.18 , pp. 137-144
    • Phillips, K.F.1
  • 22
  • 23
    • 36849072409 scopus 로고    scopus 로고
    • Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Rockville, Md
    • U.S. Food and Drug Administration, Center for Drug Evaluation and Research, March
    • U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. Rockville, Md.: Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, March 2003.
    • (2003) Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210
  • 24
    • 36849004979 scopus 로고    scopus 로고
    • Health Canada. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects. Ottawa, Ontario, Canada: Ministry of Health; 1992.
    • Health Canada. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects. Ottawa, Ontario, Canada: Ministry of Health; 1992.
  • 26
    • 36849009706 scopus 로고    scopus 로고
    • Medicines Control Council, Department of Health, Republic of South Africa, Pretoria, South Africa: MCC;
    • Medicines Control Council, Department of Health, Republic of South Africa. Registration of Medicines: Biostudies. Pretoria, South Africa: MCC; 2003.
    • (2003) Registration of Medicines: Biostudies
  • 27
    • 0028295970 scopus 로고
    • Unique pharmacologic properties of amlodipine
    • Burges R, Moisey D. Unique pharmacologic properties of amlodipine. Am J Cardiol. 1994;73:2A-9A.
    • (1994) Am J Cardiol , vol.73
    • Burges, R.1    Moisey, D.2
  • 28
    • 0028505188 scopus 로고
    • Amlodipine: An overview of its pharmacodynamic and pharmacokinetics properties
    • van Zwieten PA. Amlodipine: an overview of its pharmacodynamic and pharmacokinetics properties. Clin Cardiol. 1994;17:3-6.
    • (1994) Clin Cardiol , vol.17 , pp. 3-6
    • van Zwieten, P.A.1
  • 29
    • 0024456526 scopus 로고
    • Inhibition by amlodipine of activity evoked in isolated human coronary arteries by endothelin, prostaglandin F2 alpha and depolarization
    • Godfraind T, Mennig D, Bravo G, Chalant C, Jaumin P. Inhibition by amlodipine of activity evoked in isolated human coronary arteries by endothelin, prostaglandin F2 alpha and depolarization. Am J Cardiol. 1989;64:58I-64I.
    • (1989) Am J Cardiol , vol.64
    • Godfraind, T.1    Mennig, D.2    Bravo, G.3    Chalant, C.4    Jaumin, P.5
  • 30
    • 0033982436 scopus 로고    scopus 로고
    • Hypertension control in the elderly with amlodipine
    • Pascual J. Hypertension control in the elderly with amlodipine. Curr Med Res Opin. 2000;16:33-36.
    • (2000) Curr Med Res Opin , vol.16 , pp. 33-36
    • Pascual, J.1
  • 31
    • 0026350917 scopus 로고
    • Vascular and myocardial effects of amlodipine: An overview
    • Nayler WG, Gu XH. Vascular and myocardial effects of amlodipine: An overview. Postgrad Med J 1991;67:S41-S43.
    • (1991) Postgrad Med J , vol.67
    • Nayler, W.G.1    Gu, X.H.2
  • 33


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.