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http://hdl.handle.net/123456789/1911
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| Title: | Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda |
| Authors: | Obua, C
Ntale, M
Lundblad, M.S
Gustafsson, L.L
Ogwal-Okeng, J.W
Anokbonggo, W.W
Hellgren, U |
| Keywords: | Pyrimethamine
Pharmacokinetic interactions
Bioequivalence
Chloroquine
Sulfadoxine
Falciparum malaria
Children
Uganda
Antimalarial treatment |
| Issue Date: | 2006 |
| Publisher: | Makerere University Medical School |
| Citation: | Obua, C., Ntale, m., Lundblad, M.S.,Gustafsson, L.L., Ogwal-Okeng, J.W., Anokbonggo, W.W., Hellgren, U. (2006). Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda. African Health Sciences, 6(2) |
| Abstract: | Background: 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. It is however a product whose pharmacokinetics
and interactions have not been studied.
Objectives: To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their
bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations.
Methods: Thirty-two adult healthy volunteers were randomized into four groups and given single oral doses of fixed-dose CQ+S/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.
Results: Sulfadoxine in Homapak was more rapidly absorbed (ka = 0.55 h-1) than in
Fansidar + CQ (ka = 0.27 h-1, p=0.004), but not more than S in Fansidar alone group (ka = 0.32 h-1, p=0.03). 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.
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. Furthermore, the absorption of S was more rapid which could be advantageous
in malaria treatment. |
| URI: | http://hdl.handle.net/123456789/1911 |
| ISSN: | 1680-6905 |
| Appears in Collections: | Research Articles (Health-Sciences)
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| Obua-chs-res.pdf | | 186Kb | Adobe PDF | View/Open |
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