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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date01 Jan 1981 |
/ CompletedNot Applicable 磷酸芦可替尼片在中国健康人群中空腹状态下单次给药的人体生物等效性临床试验
[Translation] Human bioequivalence clinical trial of ruxolitinib phosphate tablets in healthy Chinese populations under fasting single-dose administration
主要目的:以持证商为Novartis Europharm Limited的磷酸芦可替尼片(20mg)为参比制剂,以湖北民康制药有限公司研制的磷酸芦可替尼片(20mg)为受试制剂,评价两种制剂在中国健康试验参与者中空腹状态下的生物等效性。
次要目的:评价受试制剂和参比制剂在中国健康试验参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of ruxolitinib phosphate tablets (20 mg) manufactured by Novartis Europharm Limited as the reference formulation and ruxolitinib phosphate tablets (20 mg) manufactured by Hubei Minkang Pharmaceutical Co., Ltd. as the test formulation in healthy participants in a Chinese trial under fasting conditions.
Secondary objective: To evaluate the safety of the test and reference formulations in healthy participants in a Chinese trial.
/ CompletedNot Applicable 巴瑞替尼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临床试验
[Translation] Human bioequivalence clinical trials of baricitinib tablets in healthy Chinese populations under fasting and postprandial conditions with single-dose administration
主要目的:以持证商为Eli Lilly Nederland B.V.的巴瑞替尼片(商品名:Olumiant®,规格:4mg)为参比制剂,以湖北民康制药有限公司研发的巴瑞替尼片(规格:4mg)为受试制剂,评价两种制剂在中国健康参与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参与者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of baricitinib tablets (trade name: Olumiant®, strength: 4 mg) manufactured by Eli Lilly Nederland B.V. as the reference formulation and baricitinib tablets (strength: 4 mg) developed by Hubei Minkang Pharmaceutical Co., Ltd. as the test formulation in healthy Chinese participants under fasting and postprandial conditions.
Secondary objective: To observe the safety of the test and reference formulations in healthy Chinese participants.
100 Clinical Results associated with Hubei Minkang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Hubei Minkang Pharmaceutical Co. Ltd.
100 Deals associated with Hubei Minkang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Hubei Minkang Pharmaceutical Co. Ltd.