Early clinical development of artemether-lumefantrine dispersible tablet: Palatability of three flavours and bioavailability in healthy subjects

Malaria Journal

Volumn 9, Issue 1, 2010, Pages

  Abdulla, Salim ^a   Amuri, Baraka ^a   Kabanywanyi, Abdunoor M ^a   Ubben, David ^b   Reynolds, Christine ^c   Pascoe, Steve ^c   Fitoussi, Serge ^d   Yeh, Ching Ming ^c   Nuortti, Marja ^c   Séchaud, Romain ^c   Kaiser, Günther ^c   Lefèvre, Gilbert ^c  

^a IFAKARA HEALTH INSTITUTE   (Tanzania)

^b Medicines for Malaria Venture   (Switzerland)

^c NOVARTIS PHARMA AG   (Switzerland)

^d Novartis Pharma AG ^*  (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; DIHYDROARTEMISININ; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; ETHANOLAMINE DERIVATIVE; FLAVORING AGENT; FLUORENE DERIVATIVE;

AREA UNDER THE CURVE; ARTICLE; BIOAVAILABILITY; BIOEQUIVALENCE; CHILD; DISPERSIBLE TABLET; DRUG BLOOD LEVEL; DRUG FORMULATION; FEMALE; FLAVOR; HUMAN; HUMAN EXPERIMENT; MALARIA; MALE; NORMAL HUMAN; PALATABILITY; SCHOOL CHILD; TASTE PREFERENCE; VISUAL ANALOG SCALE; ADULT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG COMBINATION; RANDOMIZED CONTROLLED TRIAL; TABLET; TANZANIA;

ADULT; ANTIMALARIALS; ARTEMISININS; BIOLOGICAL AVAILABILITY; CHILD; CROSS-OVER STUDIES; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLAVORING AGENTS; FLUORENES; HUMAN EXPERIMENTATION; HUMANS; MALE; TABLETS; TANZANIA;

EID: 77957311964     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-9-253     Document Type: Article

References (29)

1. Alternative form of artemether-lumefantrine for infants. A Teklehaimanot HD Teklehaimanot, Lancet 2008 372 1786 1787 10.1016/S0140-6736(08)61493-2 18926568
2. World malaria report 2009. World Health Organization, 2009 http://whqlibdoc.who.int/publications/2009/9789241563901-eng.pdf
3. Dispersible formulation of artemether/lumefantrine: specifically developed for infants and young children. S Abdulla I Sagara, Malar J 2009 8 Suppl 1 7 10.1186/1475-2875-8-S1-S7 19818174
4. Make medicines child size. World Health Organization, 2010 http://www.who.int/childmedicines/en/
5. Guidelines for the treatment of malaria. World Health Organization, 2 2010 http://whqlibdoc.who.int/publications/2010/9789241547925-eng.pdf
6. Coartem®: the journey to the clinic. ZG Premji, Malar J 2009 8 Suppl 1 3 10.1186/1475-2875-8-S1-S3 19818170
7. The clinical efficacy of artemether/lumefantrine (Coartem®). M Makanga S Krudsood, Malar J 2009 8 Suppl 1 5 10.1186/1475-2875-8-S1-S5 19818172
8. Safety profile of Coartem®: the evidence base. C Falade C Manyando, Malar J 2009 8 Suppl 1 6 10.1186/1475-2875-8-S1-S6 19818173
9. A clinical and pharmacokinetic trial of six doses of artemether- lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand. G Lefèvre S Looareesuwan S Treeprasertsuk S Krudsood U Silachamroon I Gathmann R Mull R Bakshi, Am J Trop Med Hyg 2001 64 247 256 11463111
10. Clinical pharmacology of artemisinin-based combination therapies. PI German FT Aweeka, Clin Pharmacokinet 2008 47 91 102 10.2165/00003088-200847020- 00002 18193915
11. Pharmacokinetics and pharmacodynamics of lumefantrine (benflumetol) in acute falciparum malaria. F Ezzet M van Vugt F Nosten S Looareesuwan NJ White, Antimicrob Agents Chemother 2000 44 697 704 10.1128/AAC.44.3.697-704.2000 10681341
12. Pharmacokinetics and electrocardiographic pharmacodynamics of artemether-lumefantrine (Riamet®) with concomitant administration of ketoconazole in healthy subjects. G Lefèvre P Carpenter C Souppart H Schmidli M McClean D Stypinski, Br J Clin Pharmacol 2002 54 485 492 10.1046/j.1365-2125.2002.01696.x 12445027
13. Understanding the pharmacokinetics of Coartem®. A Djimdé G Lefèvre, Malar J 2009 8 Suppl 1 4 10.1186/1475-2875-8-S1-S4
14. Clinical pharmacokinetics of artemether and lumefantrine (Riamet®). G Lefèvre M Thomsen, Clin Drug Invest 1999 18 467 480 10.2165/00044011- 199918060-00006
15. Clinical pharmacokinetics and pharmacodynamics of artemether- lumefantrine. NJ White M van Vugt F Ezzet, Clin Pharmacokinet 1999 37 105 125 10.2165/00003088-199937020-00002 10496300
16. The content of African diets is adequate to achieve optimal efficacy with fixed-dose artemether-lumefantrine: a review of the evidence. ZG Premji S Abdulla B Ogutu A Ndong CO Falade I Sagara N Mulure O Nwaiwu G Kokwaro, Malar J 2008 7 244 10.1186/1475-2875-7-244 19032767
17. How do you improve compliance? S Winnick DO Lucas AL Hartman D Toll, Pediatrics 2005 115 718 e724 10.1542/peds.2004-1133 15930200
18. Palatability of oral antibiotics among children in an urban primary care center. ML Angelilli M Toscani DM Matsui MJ Rieder, Arch Pediatr Adolesc Med 2000 154 267 270 10710025
19. Assessment of the palatability of antistaphylococcal antibiotics in pediatric volunteers. D Matsui A Barron MJ Rieder, Ann Pharmacother 1996 30 586 588 8792942
20. Food-effect bioavailability and fed bioequivalence studies. Food and Drug Administration: Guidance for industry, 2002 http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf
21. Development and validation of a high-performance liquid chromatography-mass spectrometry assay for the determination of artemether and its metabolite dihydroartemisinin in human plasma. C Souppart N Gauducheau N Sandrenan F Richard, J Chromatogr B Analyt Technol Biomed Life Sci 2002 774 195 203 10.1016/S1570-0232(02)00207-6 12076689
22. Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1/Corr. Committee for Medicinal products for Human Use (CHMP), 2010 http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/ 01/WC500070039.pdf
23. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. AW Boddy FC Snikeris RO Kringle GC Wei JA Oppermann KK Midha, Pharm Res 1995 12 1865 1868 10.1023/A:1016219317744 8786957
24. Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial. S Abdulla I Sagara S Borrmann U D'Alessandro R Gonzlez M Hamel B Ogutu A Mårtensson J Lyimo H Maiga P Sasi A Nahum Q Bassat E Juma L Otieno A Björkman HP Beck K Andriano M Cousin G Lefèvre D Ubben Z Premji, Lancet 2008 372 1819 1827 10.1016/S0140-6736(08)61492-0 18926569
25. Interaction trial between artemether-lumefantrine (Riamet®) and quinine in healthy subjects. G Lefèvre P Carpenter C Souppart H Schmidli JM Martin A Lane C Ward D Amakye, J Clin Pharmacol 2002 42 1147 1158 12362930
26. Fluoroartemisinin: trifluoromethyl analogues of artemether and artesunate. G Magueur B Crousse S Charneau P Grellier JP Bégué D Bonnet-Delpon, J Med Chem 2004 47 2694 2699 10.1021/jm0310333 15115411
27. Efficacy and safety of the six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in adolescents and adults: a pooled analysis of individual patient data from randomized clinical trials. EA Mueller M van Vugt W Kirch K Andriano P Hunt PI de Palacios, Acta Trop 2006 100 41 53 10.1016/j.actatropica.2006.09.007 17045558 (Pubitemid 44830005)
28. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. M Makanga Z Premji C Falade J Karbwang EA Mueller K Andriano P Hunt PI De Palacios, Am J Trop Med Hyg 2006 74 991 998 16760509
29. Efficacy and safety of artemether-lumefantrine (Coartem®) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria. C Falade M Makanga Z Premji CE Ortmann M Stockmeyer PI de Palacios, Trans R Soc Trop Med Hyg 2005 99 459 467 10.1016/j.trstmh.2004.09.013 15837358