盐酸阿那格雷胶囊在中国健康志愿者中空腹及餐后状态下的生物等效性试验
[Translation] Bioequivalence study of anagrelide hydrochloride capsules in Chinese healthy volunteers in fasting and postprandial states
主要目的:
观察盐酸阿那格雷胶囊在中国健康受试者中单次口服给药后的阿那格雷体
内动力学过程,估算相应的药代动力学参数,并以Patheon Manufacturing Services
LLC, USA生产, Shire Pharmaceutical Contracts Ltd.持证的盐酸阿那格雷胶囊 (商
品名: Agrylin)为参比制剂,进行生物等效性评价。
次要目的:
观察盐酸阿那格雷胶囊受试制剂和参比制剂在健康人体中的安全性。
[Translation] main purpose:
To observe the anagrelide body after a single oral administration of anagrelide hydrochloride capsules in Chinese healthy subjects
internal kinetic processes, estimate the corresponding pharmacokinetic parameters, and use Patheon Manufacturing Services
LLC, USA, licensed by Shire Pharmaceutical Contracts Ltd. Anagrelide Hydrochloride Capsules (commercial
Brand name: Agrylin) is the reference preparation for bioequivalence evaluation.
Secondary purpose:
To observe the safety of the test preparation and reference preparation of anagrelide hydrochloride capsules in healthy subjects.
评价单次、多次静脉滴注银杏内酯B注射液在中国健康受试者体内的安全性和耐受性的Ⅰ期临床试验研究
[Translation] Phase I clinical trial study to evaluate the safety and tolerability of single and multiple intravenous infusion of Ginkgolide B injection in Chinese healthy subjects
评价单次、多次静脉滴注银杏内酯B注射液在中国健康受试者体内的安全性和耐受性
[Translation] To evaluate the safety and tolerability of single and multiple intravenous infusion of ginkgolide B injection in healthy Chinese subjects
盐酸阿那格雷胶囊随机、开放、两周期、两交叉单次空腹/餐后状态下中国成年健康受试者人体生物等效性试验
[Translation] A randomized, open-label, two-cycle, two-crossover single-dose fasting/postprandial bioequivalence trial of anagrelide hydrochloride capsules in Chinese adult healthy subjects
考察中国成年健康受试者空腹/餐后单次口服受试制剂盐酸阿那格雷胶囊的人体药代动力学特征,并与已上市的盐酸阿那格雷胶囊为参比制剂,两周期、两交叉设计进行人体生物等效性研究,并观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Investigate the human pharmacokinetic characteristics of the test preparation Anagrelide Hydrochloride Capsules in Chinese adult healthy subjects on an empty stomach/after meals, and use the marketed Anagrelide Hydrochloride Capsules as the reference preparation. A human bioequivalence study is designed to observe the safety of the test and reference products in healthy subjects.
100 Clinical Results associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.
100 Deals associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.