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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date28 Sep 2000 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date01 Jan 1995 |
/ Not yet recruitingNot Applicable 异维A酸软胶囊在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of isotretinoin soft capsules in healthy volunteers under fasting/fed conditions
主要研究目的:
本研究以弘健制药(上海)有限公司提供的异维A酸软胶囊为受试制剂,Roche Products Limited持证的异维A酸软胶囊(商品名:Roaccutane)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要研究目的:
观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose:
This study uses the isotretinoin soft capsules provided by Hongjian Pharmaceutical (Shanghai) Co., Ltd. as the test preparation and the isotretinoin soft capsules (trade name: Roaccutane) certified by Roche Products Limited as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary research purpose:
Observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Hongjian Pharmaceutical (Shanghai) Co., Ltd.
0 Patents (Medical) associated with Hongjian Pharmaceutical (Shanghai) Co., Ltd.
100 Deals associated with Hongjian Pharmaceutical (Shanghai) Co., Ltd.
100 Translational Medicine associated with Hongjian Pharmaceutical (Shanghai) Co., Ltd.