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Thirteen-week repeated oral dose toxicity study of ecabapide, a gastroprokinetic drug, in dogs and rats.
Jindo, T; Genda, Y; Kakihata, K; Ohno, H; Akiyama, Y.
Afiliación
  • Jindo T; Drug Safety Research Laboratory, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
J Toxicol Sci ; 23 Suppl 3: 561-74, 1998 Jul.
Article en En | MEDLINE | ID: mdl-9760413
Thirteen-week oral repeated dose toxicity of ecabapide, a gastroprokinetic drug, was investigated in dogs at dosage levels of 50, 175 or 600 mg/kg, and in rats at dosage levels of 25, 100, 400 or 1600 mg/kg. In dogs, vomiting, aqueous salivation, body weight gain inhibition, and hemolytic anemia, together with an increase in Heinz body formation, were observed at 175 and/or 600 mg/kg. Histological examination revealed enhanced hemosiderin deposition in the liver and spleen, retention of erythrocytes in the splenic sinus and enhanced erythropoiesis in bone marrow at 175 and/or 600 mg/kg. In the rat study, although increases in serum total protein, albumin and calcium, as well as increased liver and kidney weights, were observed at 400 and/or 1600 mg/kg, no obvious morphological changes were seen. The hemolytic anemia and an increased Heinz body formation were not observed in rats, indicating a species difference. On the basis of these results, the non-toxic dose of ecabapide was considered to be 50 mg/kg in dogs and 100 mg/kg in rats.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzamidas / Antiulcerosos Límite: Animals Idioma: En Revista: J Toxicol Sci Año: 1998 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Benzamidas / Antiulcerosos Límite: Animals Idioma: En Revista: J Toxicol Sci Año: 1998 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón