An Open, Multi-Dose, Crossover Study of Quinine, as Capsules, Tablets and Intravenous Infusion in Normal Volunteers

摘要

The study was designed to determine whether the form of quinine administration resulted in any significant difference in the incidence of adverse effects, the development of physiological or biochemical abnormalities or resulted in significant differences in blood or urine quinine concentrations. The study was an open three way crossover utilizing twelve young male volunteer subjects and each subject received the capsules, tablets and the intravenous infusion in random fashion. This study demonstrated the following: (1) diarrhea was significantly more frequent in those subjects receiving quinine orally (either tablets or capsules); (2) thrombophlebitis occurred in 2 of the 12 subjects receiving an I.V. infusion of quinine; (3) tinnitus and burning abdominal or chest pain occurred with approximately equal frequency during all three treatment modes. Laboratory studies demonstrated no significant difference when the three quinine forms were compared (excluding subject number 03), however all three treatment forms demonstrated an increase in % polymorphonuclear leukocytes and a decrease in the % lymphocytes following quinine administration.