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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2009-08

AUTHORS

Visweswaran Navaratnam, Surash Ramanathan, Mohd Suhaimi Ab. Wahab, Gan Siew Hua, Sharif Mahsufi Mansor, Jean-René Kiechel, Michel Vaillant, Walter R. J. Taylor, Piero Olliaro

ABSTRACT

OBJECTIVE: There is limited pharmacokinetic data available for the combination artesunate + amodiaquine, which is used widely to treat uncomplicated malaria. This study examines the bioavailability and tolerability of a fixed (200 mg artesunate + 540 mg amodiaquine) and loose (200 mg + 612 mg) combination with a 2x2 cross-over design in 24 healthy volunteers. METHODS: Parent compounds and metabolites [dihydroartemisinin (DHA) and desethylamodiaquine (DEAQ)] were measured by high-performance liquid chromatography-electrochemical detection, and the area under the curve (AUC)(0-t) and C(max) were compared by an analysis of variance (ANOVA) based on geometric least square means using the Schuirmann two one-sided test. RESULTS: The AUC(0-t) for total DHA and DEAQ were 1522 +/- 633 and 30021 +/- 14211 ng h/ml for the fixed products and 1688 +/- 767 and 40261 +/- 19824 ng h/ml (mean +/- standard deviation) for the loose products. The ANOVA showed no statistical differences except for sequence effect for DHA. The values obtained with the fixed product were within the 125% bioequivalent limits but extend below the 80% bioequivalence limits. CONCLUSION: Both combinations were well tolerated and had comparable pharmacokinetic profiles; differences are unlikely to be clinically relevant. More... »

PAGES

809-821

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00228-009-0656-1

DOI

http://dx.doi.org/10.1007/s00228-009-0656-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1026676730

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/19404632


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N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s00228-009-0656-1'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00228-009-0656-1'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00228-009-0656-1'


 

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