[Translation] A randomized, open, single-dose, two-formulation, two-cycle, crossover bioequivalence study of omeprazole sodium bicarbonate capsules in humans
主要研究目的:评估河北仁合益康药业有限公司生产的奥美拉唑碳酸氢钠胶囊(规格:奥美拉唑 20mg/碳酸氢钠 1100mg)与 SALIX PHARMACEUTICALS 生产的奥美拉唑碳酸氢钠胶囊(商品名:ZEGERID®,规格:奥美拉唑20mg/碳酸氢钠 1100mg)在健康受试者中空腹状态下的生物等效性。
次要研究目的:观察受试制剂和参比制剂奥美拉唑碳酸氢钠胶囊在健康受试者中的安全性。
[Translation] Primary study objective: To evaluate the bioequivalence of Omeprazole Sodium Bicarbonate Capsules (Specifications: Omeprazole 20mg/Sodium Bicarbonate 1100mg) produced by Hebei Renhe Yikang Pharmaceutical Co., Ltd. and Omeprazole Sodium Bicarbonate Capsules (Trade name: ZEGERID®, Specifications: Omeprazole 20mg/Sodium Bicarbonate 1100mg) produced by SALIX PHARMACEUTICALS in healthy subjects under fasting conditions.
Secondary study objective: To observe the safety of the test preparation and the reference preparation Omeprazole Sodium Bicarbonate Capsules in healthy subjects.