/ CompletedNot Applicable [Translation] Study on the bioequivalence of sofalcone granules in healthy volunteers
本试验旨在研究单次餐后口服南京丰恺思药物研发有限公司持证的索法酮颗粒(20%(0.5g/袋))的药代动力学特征;以大正製薬株式会社持证、生产的索法酮细粒(Solon®,20%(0.5g/袋))为参比制剂,比较两制剂药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This trial is designed to study the pharmacokinetic characteristics of sofarone granules (20% (0.5g/bag)) licensed by Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. after a single oral administration; licensed by Taisho Pharmaceutical Co., Ltd. , the produced Solon® fine granules (Solon®, 20% (0.5g/bag)) are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations are compared, and the human biological effects of the two preparations are evaluated. effectiveness.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of sofalcone granules in healthy volunteers
本试验旨在研究单次餐后口服南京丰恺思药物研发有限公司持证的索法酮颗粒(20%(0.5g/袋))的药代动力学特征;以大正製薬株式会社持证、生产的索法酮细粒(Solon®,20%(0.5g/袋))为参比制剂,比较两制剂药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This trial is designed to study the pharmacokinetic characteristics of sofarone granules (20% (0.5g/bag)) licensed by Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. after a single oral administration; licensed by Taisho Pharmaceutical Co., Ltd. , the produced Solon® fine granules (Solon®, 20% (0.5g/bag)) are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞ of the two preparations are compared, and the human biological effects of the two preparations are evaluated. effectiveness.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of sofalcone granules in healthy volunteers
本试验旨在研究单次空腹口服南京丰恺思药物研发有限公司持证的索法酮颗粒(20%(0.5g/袋))的药代动力学特征;以大正製薬株式会社持证、生产的索法酮细粒(Solon®,20%(0.5g/袋))为参比制剂,比较两制剂药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This trial is designed to study the pharmacokinetic characteristics of sofarone granules (20% (0.5g/bag)) licensed by Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd. after a single fasting oral administration; The produced Solon® fine granules (Solon®, 20% (0.5g/bag)) are used as reference preparations. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations are compared to evaluate the human bioequivalence of the two preparations. sex.
100 Clinical Results associated with Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd.
0 Patents (Medical) associated with Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd.
100 Deals associated with Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd.
100 Translational Medicine associated with Nanjing Fengkaisi Pharmaceutical Research and Development Co., Ltd.