메뉴 건너뛰기




Volumn 65, Issue 8, 2009, Pages 809-821

Tolerability and pharmacokinetics of non-fixed and fixed combinations of artesunate and amodiaquine in Malaysian healthy normal volunteers

Author keywords

Amodiaquine; Artesunate; Fixed combination treatment; Non fixed combination treatment; Pharmacokinetics; Tolerability

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; AMODIAQUINE; AMODIAQUINE PLUS ARTESUNATE; ARTESUNATE; ASPARTATE AMINOTRANSFERASE; CALCIUM ION; CREATININE; DEETHYLAMODIAQUINE; DIHYDROARTEMISININ; FLAVOQUIN; HEMOGLOBIN; POTASSIUM ION; SODIUM ION; UNCLASSIFIED DRUG; URIC ACID;

EID: 70349595536     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0656-1     Document Type: Article
Times cited : (41)

References (32)
  • 1
    • 70349603710 scopus 로고    scopus 로고
    • World Health Organisation 1 World Health Organisation, Geneva. Available at:
    • World Health Organisation (2008) World Malaria Report 2008 WHO/HTM/MAL/2008.1 World Health Organisation, Geneva. Available at: http://www.who.int/malaria/wmr2008/. Cited 12 Feb 2009
    • (2008) World Malaria Report 2008 WHO/HTM/MAL/2008
  • 2
    • 31444454856 scopus 로고    scopus 로고
    • World Health Organisation WHO/HTM/MAL/2006.1108. World Health Organisation, Geneva. Available at:
    • World Health Organisation (2006) Guidelines for the treatment of malaria. WHO/HTM/MAL/2006.1108. World Health Organisation, Geneva. Available at: http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Cited 17 July 2008.
    • (2006) Guidelines for the Treatment of Malaria
  • 3
    • 0030271322 scopus 로고    scopus 로고
    • Strategies for the prevention of antimalarial drug resistance: Rationale for combination chemotherapy for malaria
    • DOI 10.1016/0169-4758(96)10055-7
    • NJ White PL Olliaro 1996 Strategies for the prevention of antimalarial drug resistance: rationale for combination chemotherapy for malaria Parasitol Today 12 399 401 15275291 10.1016/0169-4758(96)10055-7 1:STN:280: DC%2BD2M7ovVyguw%3D%3D (Pubitemid 26306804)
    • (1996) Parasitology Today , vol.12 , Issue.10 , pp. 399-401
    • White, N.J.1    Olliaro, P.L.2
  • 4
    • 0033793944 scopus 로고    scopus 로고
    • Plasmodium falciparum antimalarial drug susceptibility on the north-western border of Thailand during five years of extensive use of artesunate-mefloquine
    • 11132385 10.1016/S0035-9203(00)90080-4 1:CAS:528:DC%2BD3cXot1WjsL4%3D
    • A Brockman RN Price M van Vugt DG Heppner D Walsh P Sookto T Wimonwattrawatee S Looareesuwan NJ White F Nosten 2000 Plasmodium falciparum antimalarial drug susceptibility on the north-western border of Thailand during five years of extensive use of artesunate-mefloquine Trans R Soc Trop Med Hyg 94 537 544 11132385 10.1016/S0035-9203(00)90080-4 1:CAS:528:DC%2BD3cXot1WjsL4%3D
    • (2000) Trans R Soc Trop Med Hyg , vol.94 , pp. 537-544
    • Brockman, A.1    Price, R.N.2    Van Vugt, M.3    Heppner, D.G.4    Walsh, D.5    Sookto, P.6    Wimonwattrawatee, T.7    Looareesuwan, S.8    White, N.J.9    Nosten, F.10
  • 5
    • 0345491020 scopus 로고    scopus 로고
    • Declining concentrations of dihydroartemisinin in plasma during 5-day oral treatment with artesunate for Falciparum malaria
    • 10049291 1:CAS:528:DyaK1MXhsF2hu7k%3D
    • NX Khanh PJ de Vries LD Ha CJ van Boxtel R Koopmans PA Kager 1999 Declining concentrations of dihydroartemisinin in plasma during 5-day oral treatment with artesunate for Falciparum malaria Antimicrob Agents Chemother 43 690 692 10049291 1:CAS:528:DyaK1MXhsF2hu7k%3D
    • (1999) Antimicrob Agents Chemother , vol.43 , pp. 690-692
    • Khanh, N.X.1    De Vries, P.J.2    Ha, L.D.3    Van Boxtel, C.J.4    Koopmans, R.5    Kager, P.A.6
  • 9
    • 0036154008 scopus 로고    scopus 로고
    • Amodiaquine clearance and its metabolism to N-desethylamodiaquine is mediated by CYP2C8: A new high affinity and turnover enzyme-specific probe substrate
    • DOI 10.1124/jpet.300.2.399
    • XQ Li A Björkman TB Andersson M Ridderström CM Masimirembwa 2002 Amodiaquine clearance and its metabolism to N-desethylamodiaquine is mediated by CYP2C8: a new high affinity and turnover enzyme-specific probe substrate J Pharmacol Exp Ther 300 399 407 11805197 10.1124/jpet.300.2.399 1:CAS:528:DC%2BD38Xos1ynsw%3D%3D (Pubitemid 34106229)
    • (2002) Journal of Pharmacology and Experimental Therapeutics , vol.300 , Issue.2 , pp. 399-407
    • Li, X.-Q.1    Bjorkman, A.2    Andersson, T.B.3    Ridderstrom, M.4    Masimirembwa, C.M.5
  • 11
    • 0023628910 scopus 로고
    • Disposition of monodesethylamodiaquine after a single oral dose of amodiaquine and three regimens for prophylaxis against Plasmodium falciparum malaria
    • DOI 10.1007/BF00637639
    • E Pussard F Verdier F Faurisson JM Scherrmann J Le Bras MC Blayo 1987 Disposition of monodesethylamodiaquine after a single oral dose of amodiaquine and three regimens for prophylaxis against Plasmodium falciparum malaria Eur J Clin Pharmacol 33 409 414 3327698 10.1007/BF00637639 1:CAS:528: DyaL1cXhtVGqtbk%3D (Pubitemid 17164966)
    • (1987) European Journal of Clinical Pharmacology , vol.33 , Issue.4 , pp. 409-414
    • Pussard, E.1    Verdier, F.2    Faurisson, F.3    Scherrmann, J.M.4    Le Bras, J.5    Blayo, M.C.6
  • 12
    • 0023502248 scopus 로고
    • Effect of dose size on amodiaquine pharmacokinetics after oral administration
    • DOI 10.1007/BF00637573
    • PA Winstanley G Edwards ML Orme AM Breckenridge 1987 Effect of dose size on amodiaquine pharmacokinetics after oral administration Eur J Clin Pharmacol 33 331 333 3691624 10.1007/BF00637573 1:CAS:528:DyaL1cXjtFaksg%3D%3D (Pubitemid 18001940)
    • (1987) European Journal of Clinical Pharmacology , vol.33 , Issue.3 , pp. 331-333
    • Winstanley, P.A.1    Edwards, G.2    Orme, L.E.M.3    Breckenridge, A.M.4
  • 13
    • 0030959661 scopus 로고    scopus 로고
    • Simultaneous determination of artesunic acid and dihydroartemisinin in blood plasma by high-performance liquid chromatography for application in clinical pharmacological studies
    • DOI 10.1016/S0378-4347(96)00505-1, PII S0378434796005051
    • V Navaratnam MN Mordi SM Mansor 1997 Simultaneous determination of artesunic acid and dihydroartemisinin in blood plasma by high-performance liquid chromatography for application in clinical pharmacological studies J Chromatogr B Biomed Sci Appl 692 157 162 9187395 10.1016/S0378-4347(96)00505-1 1:CAS:528:DyaK2sXisFKmurw%3D (Pubitemid 27208477)
    • (1997) Journal of Chromatography B: Biomedical Applications , vol.692 , Issue.1 , pp. 157-162
    • Navaratnam, V.1    Mordi, M.N.2    Mansor, S.M.3
  • 16
    • 0003922013 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Washington D.C. Available at
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (2001) Guidance for industry: statistical approaches to establishing bioequivalence. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Washington D.C. Available at: http://www.fda.gov/cder/Guidance/3616fnl.pdf. Cited 17 July 2008
    • (2001) Guidance for Industry: Statistical Approaches to Establishing Bioequivalence
  • 17
    • 0003478656 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products The European Agency for the Evaluation of Medicinal Products, Basel. Available at
    • Committee for Proprietary Medicinal Products (2001). Note for guidance on the investigation of bioavailability and bioequivalence. The European Agency for the Evaluation of Medicinal Products, Basel. Available at: http://www.emea.europa.eu/pdfs/human/qwp/140198en.pdf. Cited 17 July 2008
    • (2001) Note for Guidance on the Investigation of Bioavailability and Bioequivalence
  • 18
    • 1442324699 scopus 로고    scopus 로고
    • Plasmodium falciparum-Based Bioassay for Measurement of Artemisinin Derivatives in Plasma or Serum
    • DOI 10.1128/AAC.48.3.954-960.2004
    • P Teja-Isavadharm JO Peggins TG Brewer NJ White HK Webster DE Kyle 2004 Plasmodium falciparum-based bioassay for measurement of artemisinin derivatives in plasma or serum Antimicrob Agents Chemother 48 954 960 14982789 10.1128/AAC.48.3.954-960.2004 1:CAS:528:DC%2BD2cXitVGhtLw%3D (Pubitemid 38280349)
    • (2004) Antimicrobial Agents and Chemotherapy , vol.48 , Issue.3 , pp. 954-960
    • Teja-Isavadharm, P.1    Peggins, J.O.2    Brewer, T.G.3    White, N.J.4    Webster, H.K.5    Kyle, D.E.6
  • 19
    • 57749099137 scopus 로고    scopus 로고
    • Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium. Evidence of artemisinin-resistant malaria in western Cambodia
    • 10.1056/NEJMc0805011
    • H Noedl Y Se K Schaecher BL Smith D Socheat MM Fukuda 2001 Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium. Evidence of artemisinin-resistant malaria in western Cambodia N Engl J Med 359 24 2619 2620 10.1056/NEJMc0805011
    • (2001) N Engl J Med , vol.359 , Issue.24 , pp. 2619-2620
    • Noedl, H.1    Se, Y.2    Schaecher, K.3    Smith, B.L.4    Socheat, D.5    Fukuda, M.M.6
  • 20
    • 70349602342 scopus 로고    scopus 로고
    • Submitted to
    • Sirimi et al; Submitted to
    • Et Al, S.1
  • 21
    • 38449094920 scopus 로고    scopus 로고
    • Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal
    • DOI 10.1186/1475-2875-6-150
    • P Brasseur P Agnamey O Gaye M Vaillant WR Taylor PL Olliaro 2007 Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal Malar J 6 150 18005408 10.1186/1475-2875-6-150 (Pubitemid 351143782)
    • (2007) Malaria Journal , vol.6 , pp. 150
    • Brasseur, P.1    Agnamey, P.2    Gaye, O.3    Vaillant, M.4    Taylor, W.R.5    Olliaro, P.L.6
  • 22
    • 58449112127 scopus 로고    scopus 로고
    • Dosing accuracy of artesunate and amodiaquine as treatment for falciparum malaria in Casamance, Senegal
    • 19021893 10.1111/j.1365-3156.2008.02190.x 1:CAS:528:DC%2BD1MXislWjtr4%3D
    • P Brasseur P Agnamey O Gaye M Cisse M Badiane M Vaillant WR Taylor P Olliaro 2009 Dosing accuracy of artesunate and amodiaquine as treatment for falciparum malaria in Casamance, Senegal Trop Med Int Health 14 1 79 87 19021893 10.1111/j.1365-3156.2008.02190.x 1:CAS:528:DC%2BD1MXislWjtr4%3D
    • (2009) Trop Med Int Health , vol.14 , Issue.1 , pp. 79-87
    • Brasseur, P.1    Agnamey, P.2    Gaye, O.3    Cisse, M.4    Badiane, M.5    Vaillant, M.6    Taylor, W.R.7    Olliaro, P.8
  • 24
    • 44449129845 scopus 로고    scopus 로고
    • Pharmacokinetics and tolerability of artesunate and amodiaquine alone and in combination in healthy volunteers
    • 18415093 10.1007/s00228-007-0452-8 1:CAS:528:DC%2BD1cXmtlSjsrg%3D
    • C Orrell F Little P Smith P Folb W Taylor P Olliaro KI Barnes 2008 Pharmacokinetics and tolerability of artesunate and amodiaquine alone and in combination in healthy volunteers Eur J Clin Pharmacol 64 683 690 18415093 10.1007/s00228-007-0452-8 1:CAS:528:DC%2BD1cXmtlSjsrg%3D
    • (2008) Eur J Clin Pharmacol , vol.64 , pp. 683-690
    • Orrell, C.1    Little, F.2    Smith, P.3    Folb, P.4    Taylor, W.5    Olliaro, P.6    Barnes, K.I.7
  • 25
    • 34447569316 scopus 로고    scopus 로고
    • Amodiaquine metabolism is impaired by common polymorphisms in CYP2C8: Implications for malaria treatment in Africa
    • DOI 10.1038/sj.clpt.6100122, PII 6100122
    • S Parikh JB Ouedraogo JA Goldstein PJ Rosenthal DL Kroetz 2007 Amodiaquine metabolism is impaired by common polymorphisms in CYP2C8: implications for malaria treatment in Africa Clin Pharmacol Ther 82 197 203 17361129 10.1038/sj.clpt.6100122 1:CAS:528:DC%2BD2sXptVyrsrw%3D (Pubitemid 47075331)
    • (2007) Clinical Pharmacology and Therapeutics , vol.82 , Issue.2 , pp. 197-203
    • Parikh, S.1    Ouedraogo, J.-B.2    Goldstein, J.A.3    Rosenthal, P.J.4    Kroetz, D.L.5
  • 26
    • 0036168512 scopus 로고    scopus 로고
    • Oral artesunate dose-response relationship in acute falciparum malaria
    • DOI 10.1128/AAC.46.3.778-782.2002
    • BJ Angus I Thaiaporn K Chanthapadith Y Suputtamongkol NJ White 2002 Oral artesunate dose-response relationship in acute Falciparum malaria Antimicrob Agents Chemother 46 778 782 11850261 10.1128/AAC.46.3.778-782.2002 1:CAS:528:DC%2BD38XhsVKhtbk%3D (Pubitemid 34157663)
    • (2002) Antimicrobial Agents and Chemotherapy , vol.46 , Issue.3 , pp. 778-782
    • Angus, B.J.1    Thaiaporn, I.2    Chanthapadith, K.3    Suputtamongkol, Y.4    White, N.J.5
  • 30
    • 0031825738 scopus 로고    scopus 로고
    • Comparative pharmacokinetic study of oral and rectal formulations of artesunic acid in healthy volunteers
    • DOI 10.1007/s002280050484
    • V Navaratnam SM Mansor MN Mordi A Akbar MN Abdullah 1998 Comparative pharmacokinetic study of oral and rectal formulations of artesunic acid in healthy volunteers Eur J Clin Pharmacol 54 411 414 9754985 10.1007/s002280050484 1:CAS:528:DyaK1cXltVSqtb8%3D (Pubitemid 28396314)
    • (1998) European Journal of Clinical Pharmacology , vol.54 , Issue.5 , pp. 411-414
    • Navaratnam, V.1    Mansor, S.M.2    Mordi, M.N.3    Akbar, A.4    Abdullah, M.N.5
  • 31
    • 0442307497 scopus 로고    scopus 로고
    • Antimalarial Drug Toxicity: A Review
    • DOI 10.2165/00002018-200427010-00003
    • WR Taylor NJ White 2004 Antimalarial drug toxicity: a review Drug Saf 27 25 61 14720085 10.2165/00002018-200427010-00003 1:CAS:528:DC%2BD2cXhsl2lu7g%3D (Pubitemid 38186936)
    • (2004) Drug Safety , vol.27 , Issue.1 , pp. 25-61
    • Taylor, W.R.J.1    White, N.J.2
  • 32
    • 0035467570 scopus 로고    scopus 로고
    • Acute asymptomatic hepatitis in a healthy normal volunteer exposed to 2 oral doses of amodiaquine and artesunate
    • DOI 10.1016/S0035-9203(01)90024-0
    • C Orrell WR Taylor P Olliaro 2001 Acute asymptomatic hepatitis in a healthy normal volunteer exposed to 2 oral doses of amodiaquine and artesunate Trans R Soc Trop Med Hyg 95 517 518 11706664 10.1016/S0035-9203(01)90024-0 1:STN:280:DC%2BD3MnlsVWhtA%3D%3D (Pubitemid 34947408)
    • (2001) Transactions of the Royal Society of Tropical Medicine and Hygiene , vol.95 , Issue.5 , pp. 517-518
    • Orrell, C.1    Taylor, W.R.J.2    Olliaro, P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.