Antimalarial Drug Program. Phase I. Clinical Testing.
Abstract
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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 1979
- Accession Number
- ADA073116
Entities
People
- Richard C. Reba