/ CompletedNot Applicable [Translation] Study on the bioequivalence of clarithromycin granules in healthy volunteers
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计评价新华制药(高密)有限公司生产的克拉霉素颗粒(规格:0.125 g)与ABBVIE S.R.L.持证的克拉霉素干混悬剂(商品名:Klacid,规格:125 mg/5 mL)在健康人群中空腹、餐后口服的生物等效性,并评价新华制药(高密)有限公司生产的克拉霉素颗粒(规格:0.125 g)的安全性。
[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose design was used to evaluate the bioequivalence of clarithromycin granules (specification: 0.125 g) produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd. and clarithromycin dry suspension (trade name: Klacid, specification: 125 mg/5 mL) certified by ABBVIE S.R.L. in healthy people when taken orally on an empty stomach or after a meal, and to evaluate the safety of clarithromycin granules (specification: 0.125 g) produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of ibuprofen suspension in healthy volunteers
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较空腹和餐后给药条件下,新华制药(高密)有限公司委托山东益康药业股份有限公司生产的布洛芬混悬液(100 mL/2 g)与上海强生制药有限公司生产的布洛芬混悬液(商品名:美林®,规格:100 mL/2 g)在中国健康人群吸收程度和吸收速度的差异,并评价新华制药(高密)有限公司的布洛芬混悬液的安全性。
[Translation] A single-center, randomized, open, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and rate of ibuprofen suspension (100 mL/2 g) produced by Shandong Yikang Pharmaceutical Co., Ltd. and ibuprofen suspension (trade name: Motrin®, specification: 100 mL/2 g) produced by Shanghai Johnson & Johnson Pharmaceuticals Co., Ltd. under fasting and postprandial administration conditions in healthy Chinese people, and to evaluate the safety of ibuprofen suspension produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd.
/ CompletedNot Applicable 盐酸地尔硫卓片健康志愿者空腹及餐后单剂量口服、随机、开放、双周期、双交叉人体生物等效性研究
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of single-dose oral administration of diltiazem hydrochloride tablets in healthy volunteers after fasting or after meals
(1)通过盐酸地尔硫卓片空腹和餐后给药的生物等效性研究,评价新华制药(高密)有限公司生产的盐酸地尔硫卓片与田辺三菱製薬生产的盐酸地尔硫卓片的生物等效性,为新华制药(高密)有限公司生产的盐酸地尔硫卓片与原研盐酸地尔硫卓片临床疗效的一致性提供证据。
(2)对盐酸地尔硫卓片的安全性进行评价。
[Translation] (1) Through the bioequivalence study of diltiazem hydrochloride tablets administered on an empty stomach and after meals, the bioequivalence of diltiazem hydrochloride tablets produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd. and diltiazem hydrochloride tablets produced by Tabe Mitsubishi Manufacturing Co., Ltd. was evaluated. Provide evidence for the consistent clinical efficacy of diltiazem hydrochloride tablets produced by Xinhua Pharmaceutical (Gaomi) Co., Ltd. and the original diltiazem hydrochloride tablets.
(2) Evaluate the safety of diltiazem hydrochloride tablets.
100 Clinical Results associated with Shandong Tianda Biochemical Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Shandong Tianda Biochemical Pharmaceutical Co. Ltd.
100 Deals associated with Shandong Tianda Biochemical Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Shandong Tianda Biochemical Pharmaceutical Co. Ltd.