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Highlights of the December 2019 drug clinical trial report

Release date: 2020-01-10 Views: 0

Source: Yaozhi  

Key information of the December drug clinical trial report:

There were 67 clinical trials of BE clinical trials registered in December, of which 34 were clinical trials for conformity assessment

The hottest registered varieties in December are omeprazole enteric-coated capsules, voravir capsules ...

The most popular bidder in December is Sichuan Kelun Pharmaceutical Co., Ltd.

Drug clinical trial registration profile

In December 2019, there were a total of 215 clinical trials of drugs registered and registered in the CDE (a drop of 6.93% from the previous month), of which 162 were chemical drugs (67 were BE clinical trials of chemical drugs, 95 were clinical applications for chemical drugs), and biological products 42 , 11 Chinese medicines / natural medicines.

Drug clinical trial varieties

In December 2019, among the clinically registered varieties of drugs published by CDE, omeprazole enteric-coated capsules, voravir capsules, and HSK3486 milk injections occupied the top of the list with three registration trials, of which omeprazole enteric-coated The three registered trials of the capsules are all consistency evaluation clinical trials. Among the registered varieties top5, irbesartan dispersible tablets and montelukast sodium chewable tablets are also all consistency evaluation clinical trials. See below for details. Illustration.

Note: This chart only lists the first five clinically registered drugs of this month, and there will be an equal number of registered drugs that are not listed here. More detailed information about the products can be found in "Pharmaceutical Data Enterprise Edition_China Clinical Trials" Database ".

PS1: "Omeprazole enteric-coated capsules" occupying the top of the list with 3 registration trials were registered by two bidding units of "Zhejiang Jinhua Kangenbei Pharmaceutical Co., Ltd." and "Jinzhou Jiutai Pharmaceutical Co., Ltd." Two registration trials were registered by "Zhejiang Jinhua Kangbei Biopharmaceutical Co., Ltd.", which studied the pharmacokinetic characteristics of omeprazole enteric-coated capsules in fasting and postprandial states.

PS2: "Vararevir Capsules", which occupy the top of the list respectively, are jointly applied for registration by "Dongguan Dongguang Taijing Pharmaceutical R & D Co., Ltd./Guangdong Dongguang Pharmaceutical Co., Ltd." The purpose is as follows:

① CTR20192530: evaluate the effect of omeprazole on the pharmacokinetics of voravir capsules and emitavir phosphate capsules.

② CTR20192528: To evaluate the pharmacokinetics of rosuvastatin tablets in combination of voravir capsules and emitavir phosphate capsules.

③ CTR20192474: To evaluate the effect of food on the pharmacokinetics of single oral voraviril capsules in healthy Chinese volunteers.

PS3: "HSK3486 Milky Injection", which also occupies the top of the list, is also jointly applied for registration by three units: "Sichuan Hisco Pharmaceutical Co., Ltd./Liaoning Hisco Pharmaceutical Co., Ltd./Tibet Hisco Pharmaceutical Group Co., Ltd." The main purposes of the experimental study are as follows:

① CTR20192568: To evaluate the effect of voriconazole tablets on the pharmacokinetics (PK) of HSK3486 emulsion injection in healthy subjects.

② CTR20192535: To evaluate the pharmacokinetic characteristics of HSK3486 in healthy elderly subjects, and provide guidance for the clinical application of HSK3486.

③ CTR20192177: Comparing the pharmacokinetic characteristics (PK) of HSK3486 emulsion injection in subjects with normal renal function, subjects with mild renal impairment and subjects with moderate renal impairment, is HSK3486 emulsion injection Provide the basis for clinical application.

Clinical trials

In December 2019, 34 of the 215 clinical trial registrations announced by the CDE (down 6.93% month-on-month) were registered as consistency evaluation clinical trials, of which "Shijiazhuang Yiling Pharmaceutical Co., Ltd." agreed Sexual clinical trials have been carried out most actively. There are a total of 3 varieties of registered trials, namely glipidone tablets, glipizide tablets, and irbesartan dispersible tablets. See the table below for details.

Note: This table only lists 34 BE trials for consistency evaluation. This month, there are 33 BE trials for consistency evaluation that can be queried at "Pharmaceutics Data Enterprise Edition_China Clinical Trial Database".

Drug clinical trial status

According to the CDE announcement, as of the end of December 2019, there were a total of 9753 drug clinical trial registrations, and 4576 drug clinical trials were completed here (166 clinical trials were only completed in December), of which There are 1006 clinical trials for consistency evaluation (51 clinical trials for consistency evaluation have been completed only in November); 4891 clinical trials of drugs are in progress (including not yet recruited, recruiting, recruitment completed), Among them, 397 are clinical trials for consistent evaluation; 286 drug clinical trial sponsors have applied for active suspension of trials, of which 8 new active tentative trials were added in November, as shown in the figure below.

Highly concerned clinical trial sponsor

According to professional intelligence analysis and statistics, in December 2019, the most concerned clinical trial sponsor is "Sichuan Kelun Pharmaceutical Co., Ltd.", which has been on the list for 5 consecutive months, and finally sprinted in the forefront this month. And held the top of the list; "Jiangsu Kangyuan Pharmaceutical Co., Ltd., Hualan Biological Engineering Chongqing Co., Ltd., Zhejiang Pharmaceutical Co., Ltd." applicants have been listed this month, here are the top10 index of concern For the bidding unit, see the figure below for details.

Note: This chart only lists the first 10 applicants that are being watched this month. There will be an equal number of applicants that are not listed here. If you want to know more details, please consult the following methods.

Data source of this report: _ China clinical trial database, CDE drug clinical trial registration and information publicity platform.

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