|
|
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1981 |
克立硼罗软膏在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of a single dose of crisaborole ointment in Chinese healthy volunteers under topical conditions
主要目的:
以持证商为Anacor Pharmaceuticals, Inc.的克立硼罗软膏(2%,商品名为Staquis(舒坦明))为参比制剂,以湖北民康药业集团有限公司研制的克立硼罗软膏(2%)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、两序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的:
1)评价受试制剂与参比制剂在中国健康受试者中的安全性;
2)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main purpose:
Using the licensee Anacor Pharmaceuticals, Inc.'s crisaborole ointment (2%, trade name Staquis) as the reference preparation and the Hubei Minkang Pharmaceutical Group Co., Ltd.'s crisaborole ointment (2%) as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects.
Secondary objectives:
1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
盐酸纳呋拉啡口崩片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性
[Translation] Bioequivalence of nalfurafur hydrochloride orodisintegrating tablets in Chinese healthy subjects after single administration in fasting and fed conditions
主要目的:以持证商为東レ株式会社的盐酸纳呋拉啡口崩片(商品名:Remitch OD Tablets,规格:2.5μg)为参比制剂,以湖北民康药业集团有限公司研制的盐酸纳呋拉啡口崩片为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、两序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的: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 purpose: Using the nalfuraphine hydrochloride orally disintegrating tablets (trade name: Remitch OD Tablets, specification: 2.5 μg) of Tori Co., Ltd. as the reference preparation, and using the drug developed by Hubei Minkang Pharmaceutical Group Co., Ltd. Nafuraphine hydrochloride orally disintegrating tablets are the test preparations. A single-center, randomized, open-label, single-dose, two-preparation, two-cycle, two-sequence, crossover design clinical trial was conducted to evaluate the two preparations in healthy subjects in China. Bioequivalence in fasted and postprandial states.
Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.
利多卡因凝胶贴膏在中国健康受试者中单次给药的人体生物等效性临床试验
[Translation] Human bioequivalence clinical trial of lidocaine gel patch in Chinese healthy subjects after single administration
主要目的:
以持证商为TEIKOKU PHARMA USA INC的利多卡因凝胶贴膏(5%,商品名为Lidoderm®)为参比制剂,以湖北民康药业集团有限公司研制的利多卡因凝胶贴膏[每贴(14.0cm×10.0cm)含膏量14g,每贴含利多卡因(C14H22N2O)700mg]为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、四序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的:
1)评价受试制剂与参比制剂在中国健康受试者中的安全性;
2)评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性;
3)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main purpose:
Using lidocaine gel patch (5%, trade name Lidoderm®) from TEIKOKU PHARMA USA INC as reference preparation and lidocaine gel patch developed by Hubei Minkang Pharmaceutical Group Co., Ltd. [14g of paste per patch (14.0cm×10.0cm), 700mg of lidocaine (C14H22N2O) per patch] as test preparation, the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects was evaluated through a single-center, randomized, open, single-dose, two-preparation, two-period, four-sequence, crossover design clinical trial.
Secondary objectives:
1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) To evaluate the adhesion of the test preparation and the reference preparation during medication in Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Hubei Minkang Pharmaceutical Group Co., Ltd.
0 Patents (Medical) associated with Hubei Minkang Pharmaceutical Group Co., Ltd.
100 Deals associated with Hubei Minkang Pharmaceutical Group Co., Ltd.
100 Translational Medicine associated with Hubei Minkang Pharmaceutical Group Co., Ltd.