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MechanismH1 receptor antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date18 Dec 1996 |
/ CompletedNot Applicable [Translation] Bioequivalence study of beclomethasone dipropionate suspension for inhalation
主要试验目的:在健康受试者体内,在空腹条件下,以Chiesi Farmaceutici S.p.A. 持有的吸入用丙酸倍氯米松混悬液(规格:2 ml:0.8 mg;商品名:宝丽亚®)为参比制剂,研究河北创健药业有限公司持有的吸入用丙酸倍氯米松混悬液(规格:2 ml:0.8 mg;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] The main purpose of the study is to study the pharmacokinetics of beclomethasone dipropionate suspension for inhalation (specification: 2 ml: 0.8 mg; trade name: Baoliya®) held by Hebei Chuangjian Pharmaceutical Co., Ltd. in healthy subjects under fasting conditions, using the beclomethasone dipropionate suspension for inhalation (specification: 2 ml: 0.8 mg; trade name: Baoliya®) held by Chiesi Farmaceutici S.p.A. as the reference preparation, and evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable [Translation] Bioequivalence Study of Cinacalcet Hydrochloride Tablets
在健康受试者体内,分别在空腹和餐后条件下,评价受试制剂与参比制剂是否具有生物等效性。观察受试制剂盐酸西那卡塞片和参比制剂在健康受试者中的安全性。
[Translation] The bioequivalence of the test preparation and the reference preparation was evaluated in healthy subjects under fasting and fed conditions. The safety of the test preparation, Cinacalcet Hydrochloride Tablets, and the reference preparation in healthy subjects was observed.
/ CompletedNot Applicable 盐酸奥洛他定片5 mg随机、开放、两周期、两序列、两交叉健康人体空腹/餐后状态下生物等效性试验
[Translation] A randomized, open-label, two-period, two-sequence, two-crossover bioequivalence study of olopatadine hydrochloride tablets 5 mg in healthy volunteers under fasting and fed conditions
健康受试者空腹、餐后口服单剂量盐酸奥洛他定片(受试制剂,河北创健药业有限公司研制)与原研药—盐酸奥洛他定片(商品名:阿洛刻;参比制剂,协和发酵麒麟株式会社富士工厂(Kyowa Hakko Kirin Co.,Ltd.Fuji Plant)生产)后,测定血浆中奥洛他定的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
[Translation] After healthy subjects took a single dose of olopatadine hydrochloride tablets (test preparation, developed by Hebei Chuangjian Pharmaceutical Co., Ltd.) and the original drug, olopatadine hydrochloride tablets (trade name: Aloka; reference preparation, produced by Kyowa Hakko Kirin Co., Ltd. Fuji Plant) orally on an empty stomach or after a meal, the concentration of olopatadine in plasma was measured, the absorption rate and extent of the test preparation and the reference preparation were studied, and whether the test preparation and the reference preparation were bioequivalent was evaluated.
100 Clinical Results associated with Hebei Chuangjian Pharmaceutical Co., Ltd
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100 Deals associated with Hebei Chuangjian Pharmaceutical Co., Ltd
100 Translational Medicine associated with Hebei Chuangjian Pharmaceutical Co., Ltd