[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of benproperine phosphate tablets in healthy Chinese volunteers in the fed state

研究健康受试者餐后单次口服受试制剂磷酸苯丙哌林片（华中药业股份有限公司，规格：20mg/片）与参比制剂磷酸苯丙哌林片（商品名：Flaveric®；Pfizer Japan Inc.，规格：20mg/片）在吸收程度和速度方面是否存在差异，评价受试制剂和参比制剂在餐后条件下给药时的生物等效性，观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To investigate whether there are differences in the extent and rate of absorption of the test preparation benproperine phosphate tablets (Huazhong Pharmaceutical Co., Ltd., specification: 20 mg/tablet) and the reference preparation benproperine phosphate tablets (trade name: Flaveric®; Pfizer Japan Inc., specification: 20 mg/tablet) after a single oral administration to healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered under postprandial conditions, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Jul 2021

Sponsor / Collaborator

Hubei Huazhong Pharmaceutical Co. Ltd.

CTR20211205 / CompletedNot Applicable

中国健康受试者空腹状态下单次口服磷酸苯丙哌林片的单中心、开放、随机、两制剂、两序列、两周期、双交叉人体生物等效性试验

研究健康受试者空腹单次口服受试制剂磷酸苯丙哌林片（华中药业股份有限公司，规格：20mg/片）与参比制剂磷酸苯丙哌林片（商品名：Flaveric®；Pfizer Japan Inc.，规格：20mg/片）在吸收程度和速度方面是否存在差异，评价受试制剂和参比制剂在空腹条件下给药时的生物等效性，观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To investigate whether there are differences in the extent and rate of absorption between the test preparation benproperine phosphate tablets (Huazhong Pharmaceutical Co., Ltd., specification: 20 mg/tablet) and the reference preparation benproperine phosphate tablets (trade name: Flaveric®; Pfizer Japan Inc., specification: 20 mg/tablet) when taken orally on an empty stomach in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date26 May 2021

Sponsor / Collaborator

Hubei Huazhong Pharmaceutical Co. Ltd.

CTR20202444 / Active, not recruitingNot Applicable

中国健康受试者空腹及餐后状态下单次口服磷酸苯丙哌林片的单中心、开放、随机、两制剂、两序列、两周期、双交叉人体生物等效性预试验

[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover human bioequivalence pilot study of a single oral dose of benproperine phosphate tablets in Chinese healthy volunteers under fasting and fed conditions

研究健康受试者空腹及餐后单次口服受试制剂磷酸苯丙哌林片（华中药业股份有限公司，规格：20mg/片）与参比制剂磷酸苯丙哌林片（商品名：Flaveric®；Pfizer Japan Inc.，规格：20mg/片）在吸收程度和速度方面是否存在差异，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性，观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To investigate whether there are differences in the extent and rate of absorption of the test preparation benproperine phosphate tablets (Huazhong Pharmaceutical Co., Ltd., specification: 20 mg/tablet) and the reference preparation benproperine phosphate tablets (trade name: Flaveric®; Pfizer Japan Inc., specification: 20 mg/tablet) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date04 Dec 2020

Sponsor / Collaborator

Hubei Huazhong Pharmaceutical Co. Ltd.

100 Clinical Results associated with Benproperine Phosphate

100 Translational Medicine associated with Benproperine Phosphate

100 Patents (Medical) associated with Benproperine Phosphate

Literatures (Medical) associated with Benproperine Phosphate

01 Feb 2021·Molecular OncologyQ2 · MEDICINE

Repurposing antitussive benproperine phosphate against pancreatic cancer depends on autophagy arrest

Q2 · MEDICINE

ArticleOA

Author: Zhang, Zhe ; Zhou, Li ; Li, Qifu ; Yang, Mei ; Weng, Ningna ; Liu, Jiayang ; Ma, Lin ; Lu, Yanda ; Zhang, Huanyu ; Zheng, Shaojiang ; Qin, Siyuan ; Zhang, Xiaodian ; Huang, Yonghao

Pancreatic cancer (PC) is one of the most common human malignancies worldwide and remains a major clinical challenge. Here, we found that benproperine phosphate (BPP), a cough suppressant, showed a significant anticancer effect on PC both in vitro and in vivo via the induction of autophagy‐mediated cell death. Mechanistic studies revealed that BPP triggered AMPK/mTOR‐mediated autophagy initiation and disturbed Ras‐related protein Rab‐11A (RAB11A)‐mediated autophagosome–lysosome fusion, resulting in excessive accumulation of autophagosomes. Inhibition of autophagy or overexpression of RAB11A partially reversed BPP‐induced growth inhibition in PC cells, suggesting that BPP might induce lethal autophagy arrest in PC cells. In conclusion, our results identify BPP as a potent antitumor agent for PC via the induction of autophagy arrest, therefore providing a new potential therapeutic strategy for the treatment of PC.

01 Jan 2016·TalantaQ2 · CHEMISTRY

Highly sensitive on-site detection of drugs adulterated in botanical dietary supplements using thin layer chromatography combined with dynamic surface enhanced Raman spectroscopy

Q2 · CHEMISTRY

Article

Author: Lu, Feng ; Qi, Yunpeng ; Yang, Liangbao ; Fang, Fang

The phenomenon of botanical dietary supplements (BDS) doped with illegal adulterants has become a serious problem all over the world, which could cause great threat to human's health. Therefore, it is of great value to identify BDS. Herein, we put forward a highly sensitive method for on-site detection of antitussive and antiasthmatic drugs adulterated in BDS using thin layer chromatography (TLC) combined with dynamic surface enhanced Raman spectroscopy (DSERS). Adulterants in BDS were separated on a TLC plate and located under UV illumination. Then DSERS detection was performed using a portable Raman spectrometer with 50% glycerol silver colloid serving as DSERS active substrate. Here, the effects of different solvents on detection efficacy were evaluated using phenformin hydrochloride (PHE) as a probe. It was shown that 50% glycerol resulted in higher SERS enhancement and relatively higher stability. Moreover, practical application of this novel TLC-DSERS method was demonstrated with rapid analysis of real BDS samples and one sample adulterated with benproperine phosphate (BEN) was found. Furthermore, the obtained result was verified by ultra performance liquid chromatography-quadrupole time of flight mass spectrometry (UPLC-QTOF/MS). The sensitivity of the TLC-DSERS technique is 1-2 orders of magnitude higher than that of TLC-SERS technique. The results turned out that this combined method would have good prospects for on-site and sensitive detection of adulterated BDS.

01 Mar 2009·LuminescenceQ4 · CHEMISTRY

Resonance light scattering study on the interaction of benproperine phosphate with eriochrome blue black R in the presence of sodium dodecylbenzene sulphonate and its analytical application

Q4 · CHEMISTRY

Article

Author: Xiangming Han ; Jing Fan ; Jingjing Liu ; Suling Feng

AbstractThe interaction of benproperine phosphate (BPP) with eriochrome blue black R (EBBR) in the presence of sodium dodecylbenzene sulphonate (SDBS) was studied using resonance light scattering (RLS) technology and ultraviolet‐visual (UV‐vis) spectrophotometry. Under optimum conditions, BPP reacts with EBBP and SDBS to form a three‐component complex, which results in strong RLS signal and a new RLS peak. The enhanced RLS intensities are proportional to the concentration of BPP over the range 0.6–28.0 µg/mL, with a detection limit of 0.053 µg/mL. The affecting factors as well as the influence of coexisting substances were investigated. The results indicate that this assay method could be applied to the determination of BPP in pharmaceuticals, serum and urine samples with satisfactory results. Copyright © 2008 John Wiley & Sons, Ltd.

100 Deals associated with Benproperine Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D01427	-	R05DB02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Cough	CN	Heilongjiang Fuhe Huaxing Pharmaceutical Group Co. Ltd.	01 Jan 1986
Acute Bronchitis	JP	Pfizer Inc.	31 Mar 1970
Bronchitis, Chronic	JP	Pfizer Inc.	31 Mar 1970
Common Cold	JP	Pfizer Inc.	31 Mar 1970
Pulmonary Tuberculosis	JP	Pfizer Inc.	31 Mar 1970

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