Trial reportEuropean journal of clinical pharmacology2009
Tolerability and pharmacokinetics of non-fixed and fixed combinations of artesunate and amodiaquine in Malaysian healthy normal volunteers.
Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The cardiovascular effects of amodiaquine and structurally related antimalarials: An individual patient data meta-analysis.PLoS medicine · 2021Pooled it
- Factors affecting the electrocardiographic QT interval in malaria: A systematic review and meta-analysis of individual patient data.PLoS medicine · 2020Pooled it
- Pharmacokinetics andAntimicrobial agents and chemotherapy · 2020Trial
- Validation and pharmacokinetic application of a high-performance liquid chromatographic technique for determining the concentrations of amodiaquine and its metabolite in plasma of patients treated with oral fixed-dose amodiaquine-artesunate combination in areas of malaria endemicity.Antimicrobial agents and chemotherapy · 2015Trial
- Pharmacokinetic interactions between primaquine and pyronaridine-artesunate in healthy adult Thai subjects.Antimicrobial agents and chemotherapy · 2015Trial
- Fixed dose artesunate amodiaquine - a phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine.Malaria journal · 2014Trial
- Open-label crossover study of primaquine and dihydroartemisinin-piperaquine pharmacokinetics in healthy adult thai subjects.Antimicrobial agents and chemotherapy · 2014Trial
- A replicate designed bioequivalence study to compare two fixed-dose combination products of artesunate and amodiaquine in healthy chinese volunteers.Antimicrobial agents and chemotherapy · 2014Trial
- Pharmacokinetics of artesunate alone and in combination with sulfadoxine/pyrimethamine in healthy Sudanese volunteers.The American journal of tropical medicine and hygiene · 2014Trial
- A randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia.The Journal of infectious diseases · 2013Trial
- Pharmacokinetics of amodiaquine and desethylamodiaquine in pregnant and postpartum women with Plasmodium vivax malaria.Antimicrobial agents and chemotherapy · 2011Trial
- Comparative oral bioavailability of non-fixed and fixed combinations of artesunate and amodiaquine in healthy Indian male volunteers.European journal of clinical pharmacology · 2011Trial
- Population pharmacokinetics and pharmacodynamic considerations of amodiaquine and desethylamodiaquine in Kenyan adults with uncomplicated malaria receiving artesunate-amodiaquine combination therapy.Antimicrobial agents and chemotherapy · 2010Trial
- Pharmacokinetics and pharmacodynamics of a new ACT formulation: Artesunate/Amodiaquine (TRIMALACT) following oral administration in African malaria patients.European journal of drug metabolism and pharmacokineticsTrial
- Chemoproteomics-based profiling elucidates the antimalarial effects of amodiaquine through disruption of glycolysis process in Plasmodium falciparum.Cell communication and signaling : CCS · 2026Article
- Acute and prolonged effects of anti-malarial drugs on mitochondrial respiration in atrial cardiomyocytes for cardiac safety evaluation.PloS one · 2026Article
- A LC-MS/MS Assay for Quantification of Amodiaquine and Desethylamodiaquine in Dried Blood Spots on Filter Paper.International journal of analytical chemistry · 2025Article
- Drug repurposing against SARS-CoV-1, SARS-CoV-2 and MERS-CoV.Future microbiology · 2021Article
- High-throughput quantitation method for amodiaquine and desethylamodiaquine in plasma using supported liquid extraction technology.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2021Article
- Antimalarial artemisinin-based combination therapies (ACT) and COVID-19 in Africa: In vitro inhibition of SARS-CoV-2 replication by mefloquine-artesunate.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThere 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.
methodsParent 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.
resultsThe 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.
conclusionBoth combinations were well tolerated and had comparable pharmacokinetic profiles; differences are unlikely to be clinically relevant.
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