PRELIMINARY DOSE FINDING STUDY FOR SUBACUTE TOXICOLOGICAL STUDY OF PRAVASTATIN SODIUM IN MONKEYS

Abstract

Pravastatin sodium was orally administered to cynomolgus monkeys at dosage levels of 50, 200 and 800 mg/kg/day for 7 successive days. Excretions of diarrhea and/or loose stool were observed in the more than 50 mg/kg dose group, but the changes were quite mild. Animals of the 800 mg/kg dose group showed vomiting, diarrhed and/or excretion of soft stool and reduction of cholesterol content in serum. In conclusion, it is estimated that the no effective level is less than 200 mg/kg because no abnormalities were observed except for only very slight excretions of diarrhea and/or loose stool, and that the effective dose is 800 mg/kg in which vomiting was observed.