Multiple dose pharmacokinetics of artemether in Chinese patients with uncomplicated falciparum malaria

International Journal of Antimicrobial Agents

Volumn 12, Issue 2, 1999, Pages 151-158

  Van Agtmael, M A ^a   Cheng Qi, Shan ^b   Qing, Jiao Xiu ^b   Mull, R ^c   Van Boxtel, C J ^a  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b BEIJING INSTITUTE OF MICROBIOLOGY AND EPIDEMIOLOGY   (China)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Artemether; Auto induction; Benflumetol; Lumefantrine; Malaria; Pharmacokinetics

Indexed keywords

ARTEMETHER; BENFLUMETOL; DIHYDROARTEMISININ;

ADOLESCENT; ADULT; ARTICLE; BIOAVAILABILITY; CHINESE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; ENZYME INDUCTION; FEMALE; HUMAN; LIVER METABOLISM; MAJOR CLINICAL STUDY; MALARIA; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PLASMODIUM FALCIPARUM; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; ANTIMALARIALS; ARTEMISININS; CHINA; DOUBLE-BLIND METHOD; DRUG EVALUATION; DRUG THERAPY, COMBINATION; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; MALARIA, FALCIPARUM; MALE; MIDDLE AGED; MODELS, CHEMICAL; SESQUITERPENES; TIME FACTORS;

EID: 0033067324     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0924-8579(99)00063-1     Document Type: Article

References (33)

1. Van Hensbroek M.B., Onyiorah E., Jaffar S., Schneider G., Palmer A., Frenkel J. et al. A trial of artemether or quinine in children with cerebral malaria. N. Engl. J. Med. 335:1996;69-75.
2. Tran T.H., Day N.P., Nguyen H.P., Nguyen T.H., Pham P.L., Dinh X.S. et al. A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. N. Engl. J. Med. 335:1996;76-83.
3. Looareesuwan S. Overview of clinical studies on artemisinin derivatives in Thailand [Review]. Trans. R. Soc. Trop. Med. Hyg. 88(Suppl 1):1994;S911.
4. White N.J. Malaria. Cook G.C. Tropical Diseases. 1996;1087-1164 W.B. Saunders Ltd, London.
5. Karbwang J., NaBangchang K., Wattanakoon Y., Thanavibul A., Harinasuta T. Artemether 5 versus 7 day regimen for severe falciparum malaria. Southeast Asian J. Trop. Med. Pub. Health. 25:1994;702-706.
6. NaBangchang K., Congpuong K., Sirichaisinthop J., Suprakorb K., Karbwang J. Compliance with a 2 day course of artemethermefloquine in an area of highly multidrug resistant Plasmodium falciparum malaria. Br. J. Clin. Pharmacol. 43:1997;639-642.
7. Von Seidlein L., Jaffar S., Pinder M., Haywood M., Snounou G., Gemperli B. et al. Treatment of african children with uncomplicated falciparum malaria with a new antimalarial drug, CGP 56697. J. Inf. Dis. 176:1997;1113-1116.
8. Ezzet F., Mull R., Karbwang J. Population pharmacokinetics and therapeutic response of CGP 56697(artemether+benflumetol) in malaria patients. Br. J. Clin. Pharmacol. 46:1998;553-561.
9. Basco L.K., Bickii J., Ringwald P. In vitro activity of lumefantrine (benflumetol) against clinical isolates of Plasmodium falciparum in Yaounde, Cameroon. Antimicrob. Agents Chemother. 42:1998;2347-2351.
10. Jiao X, Liu GY, Shan CO, Zhao X, Gathmann I, Royce C. Phase II trial in China of a new, rapidly-acting and effective oral antimalarial CGP 56697 for the treatment of Plasmodium falciparum malaria. Southeast Asian J. Trop. Med. Pub. Health 28;476-481.
11. Van Vugt M, Brockman A, Gemperli B, Luxemburger C, Gathmann I, Royce C et al. Randomised comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug-resistant malaria. Antimicrob. Agents Chemother. 42,1:135-139.
12. Van Agtmael M.A., Butter J.J., Portier E.J.G., Van Boxtel C.J. Validation of an improved reversed phase high performance liquid chromatography assay with reductive electrochemical detection for the determination of artemisinin derivatives in man. Ther. Drug Monit. 20:1998;109-116.
13. Scientist, for experimental data fitting. Micromath. 1986; Scientist Handbook ed.
14. Hassan Alin M., Ashton M., Kihamia C.M., Mtey G.J., Bjorkman A. Multiple dose pharmacokinetics of oral artemisinin and comparison of its efficacy with that of oral artesunate in falciparum malaria patients. Trans. R. Soc. Trop. Med. Hyg. 90:1996;61-65.
15. Ashton M, Trinh Ngoc Hai, Nguyen Duy Sy, Dinh Xuan Huong, Nguyen van Huong, Nguyen Thi Nieu, Le Dinh Cong. Artemisinin pharmacokinetics is time-dependent during repeated oral administration in healthy male adults. Drug Metab. Dispos. 1998;26:25-27.
16. Strolin Benedetti M., Dostert P. Induction and autoinduction properties of rifamycin derivatives: a review of animal and human studies. Environ. Health Perspect. 102:1994;101-105.
17. Li R.C., Narang P.K., Poggesi I., StrolinBenedetti M. A model-based assessment of redistribution-dependent elimination and bioavailability of rifabutin. Biopharm. Drug Dispos. 17:1996;223-236.
18. Scheyer R.D., Cramer J.A., Mattson R.H. A pharmacodynamic approach to the estimate of carbamazepine autoinduction. J. Pharm. Sci. 83:1994;491494.
19. Ludden T.M. Nonlinear Pharmacokinetics. Clinical Implications. Clin. Pharmacokinet. 20:1991;429-446.
20. Karbwang J., Na-Bangchang K., Congpuong K., Thanavibul A., Wattanakoon Y., Molunto P. Pharmacokinetics of oral artemether in Thai patients with uncomplicated malaria. Fundam. Clin. Pharmacol. 12:1998;242-244.
21. Kokwaro G.O. Bioavailability of artemether. Br. J. Clin. Pharmacol. 44:1997;30321.
22. Ngo Thu Hoa, Michoel A, Kinget R. Dissolution testing of artemisinin solid oral dosage forms. Int. J. Pharm. 1996; 138:185-190.
23. Macheras P., Argyrakis P. Gastrointestinal drug absorption: is it time to consider heterogeneity as well as homogeneity? Pharm. Res. 14:1997;842-847.
24. Brewer T.G., Grate S.J., Peggins J.O., Weina P.J., Petras J.M., Levine B.S. et al. Fatal neurotoxicity of arteether and artemether. Am. J. Trop. Med. Hyg. 51:1994;251-259.
25. Looareesuwan S., Wilairatana P., Viravan C., Vanijanonta S., Pitisuttithum P. et al. Open randomized trial of oral artemether alone and a sequential combination with mefloquine for acute uncomplicated falciparum malaria. Am. J. Trop. Med. Hyg. 56:1997;613-617.
26. Skinner T.S., Manning L.S., Johnston W.A., Davis T.M. In vitro stagespecific sensitivity of Plasmodium falciparum to quinine and artemisinin drugs. Int. J. Parasitol. 26:1996;519-525.
27. Lin A.i J.eng, Klayman D.L., Milhous W.K. Antimalarial activity of new water soluble dihydroartemisinin derivatives. J. Med. Chem. 30(11):1987;2147-2150.
28. Brossi A., Venugopalan B., Dominuez Gerpe L., Yeh H.J.C., Flippen-Anderson J.L., Buchs P., Luo X.D., Milhous W., Peters W. Arteether, a New Antimalarial Drug: Synthesis and Antimalarial Properties. J. Med. Chem. 31(3):1988;645-650.
29. Karbwang J., Na-Bangchang K., Congpuong K., Molunto P., Thanavibul A. Pharmacokinetics and bioavailability of oral and intramuscular artemether. Eur. J. Clin. Pharmacol. 52:1997;307-310.
30. Na-Bangchang K., Karbwang J., Thomas C.G., Thanavibul A., Sukontason K., Ward S.A., Edwards G. Pharmacokinetics of artemether after oral administration to healthy Thai males and patients with acute, uncomplicated malaria. Br. J. Clin. Pharmacol. 37:1994;249-253.
31. Mordi M.N., Mansor S.M., Navaratnam V., Wernsdorfer W.H. Single dose pharmacokinetics of oral artemether in healthy Malaysian volunteers. Br. J. Clin. Pharmacol. 43:1997;363-365.
32. Teja-Isavadharm P., Nosten F., Kyle D.E. et al. Comparative bioavailability of oral, rectal, and intramuscular artemether in healthy subjects: use of simultaneous measurement by high performance liquid chromatography and bioassay. Br. J. Clin. Pharmacol. 42:1996;599-604.
33. Van Agtmael M.A., Van der Graaf C.A.A., Dien T.K., Koopmans R.P., van Boxtel C.J. The contribution of the enzymes CYP2D6 and CYP2C19 in the demethylation of artemether in healthy subjects. Eur. J. Drug Metab. Pharmacokinet. 23:1998;429-436.