Antimalarial Drug Program. Phase I. Clinical Testing.
Annual rept. no. 4, Feb 78-Jan 79,
BIO-MED INC WASHINGTON DC
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Pharmacokinetic comparative bioavailbaility studies of mefloquine preparations were performed in conjunction with the Department of Pharmacology, Walter Reed Army Institute of Research, and the World Health Organization. A classifical two way balanced cross-over design including 3 groups of 4 subjects each was used for this study. Two antimalarial agents underwent clinical testing using standard 2-by-2 double-blind rising dose level design. WR 194,965.H3PO4 a mannich base was well tolerated to the 1250 mg dose level, at which level 1 of 2 subjects developed gastrointestinal symptomatology. WR 172,435.CH3SO3H, a pyridinemethanol, was well tolerated to the 1000 mg dose level. At this level 3 of 4 subjects had non-incapacitating gastrointestinal symptoms of less than 12 hours duration. However, transient leukocytosis without change in the differential count occurred in 3 of the 4 subjects receiving this dose.