二甲双胍维格列汀片(II)在中国健康受试者中的单次给药、随机、开放、两周期、双交叉、空腹及餐后状态下的生物等效性研究
[Translation] Bioequivalence study of metformin vildagliptin tablets (II) in Chinese healthy subjects under single-dose, randomized, open-label, two-cycle, double-crossover, fasting and postprandial conditions
主要研究目的:以 Novartis Pharma Schweiz AG持证的二甲双胍维格列汀片(II)(规格:850 mg / 50 mg,商品名:Eucreas®)为参比制剂,以山东朗诺制药有限公司生产的二甲双胍维格列汀片(II)(规格:850 mg / 50 mg)为受试制剂,通过单中心、单次给药、随机、开放、两周期、双交叉设计的临床研究来评价两种制剂在空腹和餐后状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research purpose: Use Novartis Pharma Schweiz AG’s certified metformin vildagliptin tablets (II) (specification: 850 mg/50 mg, trade name: Eucreas®) as the reference preparation, and use the metformin vildagliptin tablets (II) produced by Shandong Langnuo Pharmaceutical Co., Ltd. Metformin Vildagliptin Tablets (II) (specification: 850 mg/50 mg) is the test preparation. The two preparations were evaluated through a single-center, single-dose, randomized, open-label, two-cycle, double-crossover design clinical study. Human bioequivalence in fasted and postprandial states.
Secondary research purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
[Translation] Study on the human bioequivalence of ezetimibe and suvastatin calcium tablets
主要目的: 本试验旨在研究单次空腹和餐后口服山东朗诺制药有限公司研制、生产的依折麦布瑞舒伐他汀钙片(10mg/10mg)的药代动力学特征;以SANOFI AVENTIS FRANCE持证、SANOFI WINTHROP INDUSTRIE-TOURS生产的依折麦布瑞舒伐他汀钙片(SUVREZA®,10mg/10mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
次要目的:观察健康受试者单次空腹和餐后口服受试制剂和参比制剂后的安全性。
[Translation] Main purpose: This trial is designed to study the pharmacokinetic characteristics of ezetimibe and suvastatin calcium tablets (10mg/10mg) taken orally on an empty stomach and after a meal in a single dose; SANOFI AVENTIS Ezetimibra and Suvastatin Calcium Tablets (SUVREZA®, 10mg/10mg), which is licensed by FRANCE and produced by SANOFI WINTHROP INDUSTRIE-TOURS, is the reference preparation. Compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations. , to evaluate the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of healthy subjects after single fasting and postprandial oral administration of the test preparation and reference preparation.
评估受试制剂吡非尼酮片(规格:0.2 g)与参比制剂吡非尼酮片(Pirespa®)(规格:0.2 g)在健康成年参与者空腹和餐后状态下的生物等效性试验
[Translation] To evaluate the bioequivalence of the test preparation pirfenidone tablets (strength: 0.2 g) and the reference preparation pirfenidone tablets (Pirespa®) (strength: 0.2 g) in healthy adult participants under fasting and postprandial conditions test
主要试验目的:研究空腹和餐后状态下单次口服受试制剂吡非尼酮片(规格:0.2 g,山东朗诺制药有限公司生产)与参比制剂吡非尼酮片(Pirespa®,规格:0.2 g;塩野義製薬株式会社生产)在健康成年参与者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:研究受试制剂吡非尼酮片(规格:0.2 g)和参比制剂吡非尼酮片(Pirespa®)(规格:0.2 g)在健康成年参与者中的安全性。
[Translation] Main purpose of the test: To study the single oral administration of the test preparation pirfenidone tablets (specification: 0.2 g, produced by Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference preparation pirfenidone tablets (Pirespa®, specifications) in fasting and postprandial states : 0.2 g; manufactured by Shionogi Seiki Co., Ltd.) in healthy adult participants to evaluate the bioequivalence of the two oral preparations in the fasting and postprandial states.
Secondary trial purpose: To study the safety of the test preparation pirfenidone tablets (specification: 0.2 g) and the reference preparation pirfenidone tablets (Pirespa®) (specification: 0.2 g) in healthy adult participants.
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