Accession Number:

ADA073116

Title:

Antimalarial Drug Program. Phase I. Clinical Testing.

Descriptive Note:

Annual rept. no. 4, Feb 78-Jan 79,

Corporate Author:

BIO-MED INC WASHINGTON DC

Personal Author(s):

Report Date:

1979-03-01

Pagination or Media Count:

243.0

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.

Subject Categories:

  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE