Single-dose safety, pharmacokinetics, and food effects studies of compound naphthoquine phosphate tablets in healthy volunteers

Journal of Clinical Pharmacology

Volumn 50, Issue 11, 2010, Pages 1310-1318

  Qu, Heng Yan ^a   Gao, Hong Zhi ^a   Hao, Guang Tao ^a   Li, Yuan Yuan ^a   Li, Hai Yan ^a   Hu, Jin Chao ^a   Wang, Xiao Fang ^a   Liu, Wei Li ^a   Liu, Ze Yuan ^a  

^a BEIJING INSTITUTE OF MICROBIOLOGY AND EPIDEMIOLOGY   (China)

Author keywords

artemisinin; food effects; naphthoquine phosphate; pharmacokinetics; safety and tolerability

Indexed keywords

ANTIMALARIAL AGENT; ARTEMISININ; NAPHTHOQUINE PHOSPHATE; UNCLASSIFIED DRUG;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG FORMULATION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; FOOD; FOOD INTAKE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; TRIACYLGLYCEROL BLOOD LEVEL; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, ORAL; ADULT; ANTIMALARIALS; AREA UNDER CURVE; ARTEMISININS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FOOD-DRUG INTERACTIONS; HUMANS; MALE; NAPHTHOQUINONES; TABLETS; TANDEM MASS SPECTROMETRY; YOUNG ADULT;

EID: 78449313860     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270009356296     Document Type: Article

References (28)

1. World Health Organization. World Malaria Report 2008. WHO/ HTM/MAL/2008.1. Geneva, Switzerland: World Health Organization; 2008.
2. Baird JK Chloroquine resistance in Plasmodium vivax. Antimicrob Agents Chemother. 2004 ; 48: 4075-4083.
3. Looareesuwan S., Harinasuta T., Chongsuphajaisiddhi T. Drug resistant malaria with special reference in Thailand. Southeast Asian J Trop Med Public Health. 1992 ; 23: 621-634.
4. Mockenhaupt FP, Bedu-Addo G., Eggelte TA, et al. Rapid increase in the prevalence of sulfadoxine-pyrimethamine resistance among Plasmodium falciparum isolated from pregnant women in Ghana. J Infect Dis. 2008 ; 198: 1545-1549.
5. Ciach M., Zong K., Kain KC, Crandall I. Reversal of mefloquine and quinine resistance in Plasmodium falciparum with NP30. Antimicrob Agents Chemother. 2003 ; 47: 2393-2396.
6. Price RN, Uhlemann AC, Brockman A., et al. Mefloquine resistance in Plasmodium falciparum and increased pfmdr1 gene copy number. Lancet. 2004 ; 364: 438-447.
7. Bosman A., Mendis KN A major transition in malaria treatment: the adoption and deployment of artemisinin-based combination therapies. Am J Trop Med Hyg. 2007 ; 77 (6 suppl). 193-197.
8. World Health Organization. Guidelines for the treatment of malaria, vol. WHO/HTM/MAL/2006.1108. Geneva, Switzerland: World Health Organization ; 2006.
9. Wang JY, Cao WC, Shan CQ, et al. Naphthoquine phosphate and its combination with artemisinine. Acta Trop. 2004 ; 89: 375-381.
10. White NJ Assessment of the pharmacodynamic properties of antimalarial drugs in vivo. Antimicrob Agents Chemother. 1997 ; 41: 1413-1422.
11. Nandakumar DN, Nagaraj VA, Vathsala PG, Rangarajan P., Padmanaban G. Curcumin-artemisinin combination therapy for malaria. Antimicrob Agents Chemother. 2006 ; 50: 1859-1860.
12. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Food-Effect Bioavailability and Fed Bioequivalence Studies. Washington, DC: US Department of Health and Human Services, Food and Drug Administration ; 2002.
13. Van Nieuwerburgh FC, Vande Casteele SR, Maes L., et al. Quantitation of artemisinin and its biosynthetic precursors in Artemisia annua L. by high performance liquid chromatography-electrospray quadrupole time-of-flight tandem mass spectrometry. J Chromatogr A. 2006 ; 1118: 180-187.
14. Messori L., Piccioli F., Eitler B., Bergonzi MC, Bilia AR, Vincieri FF Spectrophotometric and ESI-MS/HPLC studies reveal a common mechanism for the reaction of various artemisinin analogues with hemin. Bioorg Med Chem Lett. 2003 ; 13: 4055-4057.
15. Souppart C., Gauducheau N., Sandrenan N., Richard F. Development and validation of a high-performance liquid chromatography-mass spectrometry assay for the determination of artemether and its metabolite dihydroartemisinin in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 ; 774: 195-203.
16. Dien TK, DeVries PJ, Khanh NX, et al. Effect of food intake on pharmacokinetics of oral artemisinin in healthy Vietnamese subjects. Antimicrob Agents Chemother. 1997 ; 41: 1069-1072.
17. Duc DD, DeVries PJ, Khanh NX, Binh LN, Kager PA, van Boxtel CJ The pharmacokinetics of a single dose of artemisinin in healthy Vietnamese subjects. Am J Trop Med Hyg. 1994 ; 51: 785-790.
18. World Health Organization. Global Malaria Control and Elimination: Report of a Meeting on Containment of Artemisinin Tolerance, 19 January 2008. Geneva, Switzerland: World Health Organization ; 2008.
19. Elsherbiny DA, Asimus SA, Karlsson MO, Ashton M., Simonsson US A model based assessment of the CYP2B6 and CYP2C19 inductive properties by artemisinin antimalarials: implications for combination regimens. J Pharmacokinet Pharmacodyn. 2008 ; 35: 203-217.
20. Giao PT, de Vries PJ Pharmacokinetic interactions of antimalarial agents. Clin Pharmacokinet. 2001 ; 40: 343-373.
21. Orrell C., Little F., Smith P., et al. Pharmacokinetics and tolerability of artesunate and amodiaquine alone and in combination in healthy volunteers. Eur J Clin Pharmacol. 2008 ; 64: 683-690.
22. Thriemer K., Wernsdorfer G., Rojanawatsirivet C., Kolla-ritsc H., Sirichaisinthop J., Wernsdorfer WH In vitro activity of artemisinin alone and in combination with retinol against Plasmodium falciparum. Wien Klin Wochenschr. 2005 ; 117 (suppl 4). 45-48.
23. Hoetelmans RM, Mariàn K., De Pauw M., et al. Pharmacokinetic interaction between TMC114/ritonavir and tenofovir disoproxil fumarate in healthy volunteers. Br J Clin Pharmacol. 2007 ; 64: 655-661.
24. Gordi T., Huong DX, Hai TN, Nieu NT, Ashton M. Artemisinin pharmacokinetics and efficacy in uncomplicated-malaria patients treated with two different dosage regimens. Antimicrob Agents Chemother. 2002 ; 46: 1026-1031.
25. Svensson US, Ashton M., Trinh NH, et al. Artemisinin induces omeprazole metabolism in human beings. Clin Pharmacol Ther. 1998 ; 64: 160-167.
26. Schmidt LE, Dalhoff K. Food-drug interactions. Drugs. 2002 ; 62: 1481-1502.
27. Winstanley PA, Orme MLE. The effects of food on drug bioavailability. Br J Clin Pharmacol. 1989 ; 28: 621-628.
28. Singh BN Effects of food on clinical pharmacokinetics. Clin Pharmacokinet. 1999 ; 37: 213-255.