There were no pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine when the compounds were given together.
Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda.
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Study Design
A pre-packaged fixed-dose formulation of chloroquine (CQ) and sulfadoxine/pyrimethamine (S/P) combination (Homapak) is widely used for the treatment of falciparum malaria in Ugandan children. Thirty-two adult healthy volunteers were randomized into four groups and given single oral doses of fixed-dose CQS/P combination (Homapak), or GMP formulations of S/P (Fansidar), CQ (Pharco), or their combination. Plasma samples were followed for 21 days, analysed by HPLC-UV methods, with pharmacokinetic modeling using the WinNonlin software.
Study Results
Sulfadoxine in Homapak was more rapidly absorbed (ka 0.55 h(-1)) than in Fansidar CQ (ka 0.27 h(-1), p0.004), but not more than S in Fansidar alone group (ka 0.32 h(-1), p0.03). No significant differences were observed in the other pharmacokinetic parameters of S, P and CQ when given together or separately. The relative bioavailability of CQ and S in Homapak showed bioequivalence to reference formulations.
Study Conclusions
There were no pharmacokinetic interactions between CQ, S and P when the compounds were given together, however, more investigations would be needed to explore this further. Compared with GMP made drugs, both S and CQ are bioequivalent in Homapak, the Ugandan made fixed-dose formulation.
References
Obua, C. Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in uganda. Afr Health Sci. 2006; 2: 86-92..
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