/ CompletedNot Applicable 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 under fasting and fed conditions
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] Primary objective:
To observe the in vivo kinetics of anagrelide hydrochloride capsules after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and use anagrelide hydrochloride capsules (trade name: Agrylin) produced by Patheon Manufacturing Services LLC, USA and certified by Shire Pharmaceutical Contracts Ltd. as the reference preparation for bioequivalence evaluation.
Secondary objective:
To observe the safety of the test preparation and reference preparation of anagrelide hydrochloride capsules in healthy humans.
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 to evaluate the safety and tolerability of single and multiple intravenous infusions of Ginkgolide B injection in healthy Chinese 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 infusions of Ginkgolide B injection in healthy Chinese subjects
/ CompletedNot Applicable 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-period, two-crossover single-dose bioequivalence study of anagrelide hydrochloride capsules in healthy Chinese adult subjects under fasting/fed conditions
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] The pharmacokinetic characteristics of the test preparation anagrelide hydrochloride capsules were investigated after a single oral administration on an empty stomach or after a meal in healthy adult Chinese subjects. A two-period, two-crossover design was used to conduct a human bioequivalence study using the marketed anagrelide hydrochloride capsules as the reference preparation, and the safety of the test preparation and the reference preparation in healthy subjects was observed.
100 Clinical Results associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.
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100 Translational Medicine associated with Heilongjiang Tianhong Pharmaceutical Co. Ltd.