慢性疼痛受试者空腹或餐后单次口服羟考酮纳洛酮缓释片随机、开放、两序列、两周期、双交叉人体生物等效性研究
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of oxycodone-naloxone extended-release tablets on an empty stomach or after a meal in subjects with chronic pain
主要目的:以国外上市的羟考酮纳洛酮缓释片(商品名:Targinact,Napp Pharmaceuticals Limited)为参比制剂,评价甘肃农垦药物碱厂有限公司生产的的羟考酮纳洛酮缓释片与参比制剂的生物等效性;
次要目的:评价甘肃农垦药物碱厂有限公司生产的羟考酮纳洛酮缓释片的安全性。
[Translation] Main purpose: To evaluate the bioequivalence of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd. with the reference preparation (trade name: Targinact, Napp Pharmaceuticals Limited) marketed overseas;
Secondary purpose: To evaluate the safety of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd.
健康受试者空腹、餐后单次口服羟考酮纳洛酮缓释片随机、开放、两序列、两周期、双交叉人体生物等效性研究
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of oxycodone-naloxone sustained-release tablets in healthy subjects on an empty stomach or after a meal
主要目的:以国外上市的羟考酮纳洛酮缓释片(商品名:Targinact,Napp Pharmaceuticals Limited)作为参比制剂,评价甘肃农垦药物碱厂有限公司的羟考酮纳洛酮缓释片与参比制剂的生物等效性;
次要目的:评价甘肃农垦药物碱厂有限公司生产的羟考酮纳洛酮缓释片的安全性。
[Translation] Main purpose: To evaluate the bioequivalence of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd. with the reference preparation (trade name: Targinact, Napp Pharmaceuticals Limited) marketed overseas;
Secondary purpose: To evaluate the safety of the oxycodone-naloxone sustained-release tablets produced by Gansu Nongken Drug Alkali Factory Co., Ltd.
100 Clinical Results associated with Gansu Nongken Pharmaceutical Alkali Factory Co., Ltd.
0 Patents (Medical) associated with Gansu Nongken Pharmaceutical Alkali Factory Co., Ltd.
100 Deals associated with Gansu Nongken Pharmaceutical Alkali Factory Co., Ltd.
100 Translational Medicine associated with Gansu Nongken Pharmaceutical Alkali Factory Co., Ltd.