Regulatory safety pharmacology evaluation of BIA 10-2474

The present paper describes the regulatory safety pharmacology studies that were carried out to support the clinical trial application for BIA 10-2474. Animal studies complied with worldwide regulatory guidelines (e.g. EEC Council Directive 75/318/EEC and subsequent amendments). Oral administration of BIA 10-2474 at doses of 30, 100 and 300 mg/kg to male Han Wistar rats did not cause any significant physiological or behavioral changes, affect...