Preliminary dose finding study for subacute toxicological study of pravastatin sodium in monkeys

Pravastatin sodium was orally administered to cynomolgus monkeys at dosage levels of 50, 200 and 800 mg/kg/day for 7 successive days. Excretion of diarrhea and/or loose stool were observed in the more than 50 mg/kg dose group, but the changes are quite mild. Animals of the 800 mg/kg dose group showed vomiting, diarrhea 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.