Primary objective: To study the pharmacokinetics of arginine ibuprofen granules (specification: 0.4g (in terms of ibuprofen), test preparation) held by Renhe Yikang Huize Pharmaceutical Hebei Co., Ltd. in healthy subjects under fasting and postprandial conditions, using arginine ibuprofen granules (trade name: Spodek®; specification: 0.4g (in terms of ibuprofen)) held by Hainan Zanbang Pharmaceutical Co., Ltd. as the reference preparation, and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
Main purpose of the test: In healthy subjects, under fasting and postprandial conditions, evocarnet tablets (specification: 2 mg; trade name: Orkedia®) held by Kyowa Coron Co., Ltd. were used as the reference preparation. Study the pharmacokinetics of evocarnet tablets (specification: 2 mg; test preparation) developed by Renhe Yikang Huize Pharmaceutical Hebei Co., Ltd., and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary test purpose: to observe the safety of the test preparation and reference preparation in healthy subjects.
[Translation] Bioequivalence study of indobufen tablets
主要试验目的:在健康受试者体内,餐后条件下,以Pfizer Italia S.r.l 公司持有的吲哚布芬片(商品名:IBUSTRIN®;规格:200mg)为参比制剂,研究仁合益康集团有限公司持有的吲哚布芬片(规格:0.2g;受试制剂)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要试验目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation]
Primary study objective: In healthy subjects, under postprandial conditions, using indobufen tablets (trade name: IBUSTRIN®; specification: 200 mg) held by Pfizer Italia S.r.l as the reference preparation, to study the pharmacokinetics of indobufen tablets (specification: 0.2 g; test preparation) held by Renhe Yikang Group Co., Ltd., and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.