Assessment of clinical pharmacokinetic drug-drug interaction of antimalarial drugs {alpha}/{beta}-arteether and sulfadoxine-pyrimethamine [PublishAheadOfPrint]

The antimalarial drugs combination therapy is now being widely used for treatment of uncomplicated malaria. The objective of the present study was to investigate the effects of co-administration of intramuscular α/β-arteether (AE) and oral sulfadoxine-pyrimethamine (SP) on the pharmacokinetic properties of each drug as a drug–drug interaction study to support developing the fixed-dose combination therapy. Single-dose, open-label, crossover clinical trial was conducted in healthy adult Indian male volunteers (18–45 years, n=13), received single dose of AE, SP and combination dose of AE and SP. Blood samples were collected upto 21 days post administration and concentrations of α-arteether, β-arteether, sulfadoxine and pyrimethamine were determined by using validated liquid chromatography–tandem mass spectrometry method. Pharmacokinetic parameters were calculated and statistically analyzed to calculate geometric mean ratio and confidence interval. Following single dose co-administration of intramuscular AE and oral SP, the pharmacokinetic properties of α/β-arteether were not significantly affected, and α/β-arteether had no significant effect on the pharmacokinetic properties of SP in these selected groups of healthy volunteers. However, more investigations would be needed to explore this further.

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