Zegerid 临床药理学和生物药剂学评论.doc

药物评价和研究中心 申请编号 21-849 临床药理学与生物药剂学评价 Clinical Pharmacology and Biopharmaceutics Review NDA: 21-849 (SN-000) Brand Name: Zegerid Generic Name: Omeprazole Dosage form and Strength: 20 and 40 mg Capsules Route of administration: Oral Indication: Related to GI disorders Sponsor: Santarus, Inc. Type of submission: Original Clinical Division: GI and Dermatology Division OCPB Division: DCPB III Priority: Standard Submission date: 04/26/05, O 1 /04/06 OCPB Consult date: OS/10/OS Reviewer: Tien-Mien Chen, Ph.D. Team leader: Edward D. Bashaw, Pharm. D. Zegerid 临床药理学及生物药剂学评论 新药申请: 21-849 (SN-000) 商品名: Zegerid 通用名: 奥美拉唑 剂型及规格: 20 and 40 mg 胶囊剂 给药途径: 口服 不良反应: 肠胃系统紊乱 申请者: Santarus, Inc. 提交种类: 原研 临床部: 胃肠和皮肤部 OCPB 部: DCPB III 优先次序: 标准 提交日期: 04/26/05, 01 /04/06 OCPB 受理日期: OS/10/OS 评审员: Tien-Mien Chen, Ph.D. 组长: Edward D. Bashaw, Pharm. D. Ⅰ Executive Summary Omeprazole is a substituted benzimidazole that inhibits gastric acid secretion via specific inhibition of H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell.Omeprazole has been approved and marketed in the US since 1989 as Prilosec delayed release (DR) 20 and 40 mg capsules given once daily for the treatment of a variety of shoal:- and long-term GI conditions. Prilosec is an enteric-coated dosage form for delayed release purpose due tothe acid-labile nature of omeprazole. Santarus previously developed an immediate release (IR) formulation of omeprazole powder fororal