[Translation] A randomized, open-label, single-dose, two-formulation, two-period, self-crossover fasting and fed bioequivalence study of fudosteine tablets in healthy research participants

主要目的：以南京易亨制药有限公司研制的福多司坦片（规格：0.2 g）为受试制剂，按生物等效性研究的有关规定，与田辺三菱製薬株式会社生产的福多司坦片（参比制剂，商品名：Cleanal®，规格：200 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要目的：观察福多司坦片受试制剂（规格：0.2 g）和参比制剂（规格：200 mg）在健康人中的安全性。

[Translation]

Main purpose: Taking Fodorstein tablets (specification: 0.2 g) developed by Nanjing Yiheng Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence studies, it will be compared with Fodorstein produced by Tanbei Mitsubishi Co., Ltd. The relative bioavailability of tablets (reference preparation, trade name: Cleanal®, specification: 200 mg) in healthy humans was compared to examine the human bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation (specification: 0.2 g) and reference preparation (specification: 200 mg) of Fodorstein tablets in healthy people.

Start Date23 Dec 2024

Sponsor / Collaborator

Nanjing Yiheng Pharmaceutical Co., Ltd.

CTR20244044

/ CompletedNot Applicable

福多司坦片人体生物等效性试验

[Translation] Bioequivalence study of fudosteine tablets in humans

研究目的：采用单中心、随机、开放、两制剂、两周期交叉、单剂量给药设计，分别在空腹和餐后给药条件下，比较湖北舒邦药业有限公司提供的福多司坦片（规格：0.2 g）与田辺三菱製薬株式会社持证的福多司坦片（规格：0.2 g，商品名：Cleanal®）在中国健康人群中吸收程度和吸收速度的差异，并评价湖北舒邦药业有限公司提供的福多司坦片的安全性。第二次餐后试验研究目的：比较餐后条件下湖北舒邦药业有限公司提供的福多司坦片（规格：0.2 g）与田辺三菱製薬株式会社持证的福多司坦片（规格：0.2 g，商品名：Cleanal®）在中国健康人群中吸收程度和吸收速度的差异，并评价湖北舒邦药业有限公司提供的福多司坦片的安全性。

[Translation]

Research purpose: A single-center, randomized, open-label, two-preparation, two-cycle crossover, and single-dose dosing design was adopted to compare Fudosteine tablets (specifications: Specifications: 0.2 g) and Tabe Mitsubishi Co., Ltd.’s certified fudosteine tablets (specification: 0.2 g, trade name: Cleanal®) in the degree and rate of absorption in Chinese healthy people, and to evaluate the differences in Hubei Shubon Pharmaceuticals Safety of Fodorsteine Tablets offered by Ltd. The purpose of the second postprandial trial is: Compare the Fudosteine tablets (specification: 0.2 g) provided by Hubei Shubon Pharmaceutical Co., Ltd. and the Fudosteine tablets (specification: 0.2 g, trade name: Cleanal) licensed by Mitsubishi Tanbei Co., Ltd. under postprandial conditions. ® ) in Chinese healthy people, and evaluate the safety of Fudosteine tablets provided by Hubei Shubang Pharmaceutical Co., Ltd.

Start Date12 Nov 2024

Sponsor / Collaborator

Hubei Shubang Pharmaceutical Co Ltd.

CTR20242487

/ CompletedNot Applicable

福多司坦片人体生物等效性试验

[Translation] Bioequivalence study of fudosteine tablets in humans

采用单中心、随机、开放、两制剂、两周期交叉、单剂量给药设计，分别在空腹和餐后给药条件下，比较湖北舒邦药业有限公司提供的福多司坦片（规格： 0.2 g）与田辺三菱製薬株式会社持证的福多司坦片（规格： 0.2 g，商品名： Cleanal®）在中国健康人群中吸收程度和吸收速度的差异，并评价湖北舒邦药业有限公司提供的福多司坦片的安全性。

[Translation]

A single-center, randomized, open-label, two-preparation, two-cycle crossover, and single-dose dosing design was adopted to compare Fudosteine tablets provided by Hubei Shubon Pharmaceutical Co., Ltd. (Specifications: 0.2 g) and Tabe Mitsubishi Co., Ltd.’s certified fudosteine tablets (specification: 0.2 g, trade name: Cleanal®) in the degree and rate of absorption in Chinese healthy people, and to evaluate the differences in the absorption rate of Hubei Shubon Pharmaceuticals Safety of Fodorsteine Tablets offered by Ltd.

Start Date12 Aug 2024

Sponsor / Collaborator

Hubei Shubang Pharmaceutical Co Ltd.

100 Clinical Results associated with Fudosteine

100 Translational Medicine associated with Fudosteine

100 Patents (Medical) associated with Fudosteine

Literatures (Medical) associated with Fudosteine

01 Jun 2025·Toxicology and Applied Pharmacology

Fudosteine attenuates lung inflammation in mice with PM2.5-induced asthma exacerbation by inhibiting pyroptosis via the NLRP3/caspase-1/GSDMD pathway

Article

Author: Liu, Zhangquan ; Wang, Aili ; Wu, Jian ; Liu, Jianling ; Liao, Xiaoyang ; Li, Zhangwen ; Li, Zhongpeng

This study aimed to explore the potential preventive effects of fudosteine (Fud) on PM2.5-induced asthma exacerbations in a murine model. BALB/c mice were randomly allocated into six groups: control, Fud, ovalbumin (OVA), OVA+Fud, OVA+PM2.5, and OVA+PM2.5 + Fud. An asthma model was established through OVA sensitization and challenge. Compared to the OVA group, PM2.5 exposure exacerbated allergic asthma, as evidenced by increased collagen fiber deposition, goblet cell metaplasia, mucus secretion, heightened airway inflammation, elevated total cell and eosinophil counts, and upregulated levels of interleukin (IL)-1β, IL-18, and NLRP3 expression in lung tissues. Notably, fudosteine treatment mitigated these pathological changes. Western blot analysis revealed that fudosteine significantly reduced the expression of NLRP3, caspase-1, gasdermin D (GSDMD), cleaved-caspase-1, and cleaved-GSDMD in lung tissues. In conclusion, fudosteine alleviated lung inflammation, collagen deposition, and mucus secretion in PM2.5-induced asthma exacerbation, potentially by inhibiting the NLRP3 inflammasome-mediated pyroptosis pathway.

01 Nov 2024·Respiratory Investigation

Efficacy and safety of mucolytics in patients with stable chronic obstructive pulmonary disease: A systematic review and meta-analysis

Review

Author: Inaba, Ryunosuke ; Ohnishi, Hiroshi ; Tanimoto, Takuya ; Eitoku, Masamitsu

BACKGROUNDThe efficacy and safety of mucolytics in patients with chronic obstructive pulmonary disease (COPD) and chronic bronchitis or exacerbations of COPD have been reported. We conducted a systematic review and meta-analysis of mucolytics in patients with stable COPD.METHODSReports from randomized controlled trials to evaluate the efficacy and safety of mucolytics, including ambroxol, bromhexine, carbocisteine, erdosteine, fudosteine, l-methylcysteine, and N-acetylcysteine used in patients with stable COPD were searched for in PubMed, Scopus, Embase, Web of Science, the Cochrane Library, and the Igaku Cyuo Zasshi database.RESULTSTwenty-three reports with ambroxol, carbocisteine, erdosteine, l-methylcysteine, or N-acetylcysteine were included in the review. Mucolytics significantly reduced the rates of exacerbation and hospitalization, shortened the duration of antibiotic use and exacerbations, prolonged the time to first exacerbation, and had a tendency to reduce the occurrence of two or more exacerbations in patients with stable COPD compared to placebo. Mucolytics did not improve mortality, number of lost workdays, scores on St. George's respiratory questionnaire, forced expiratory volume in 1 s, or forced vital capacity. The safety profile of mucolytics was comparable to that of placebo.CONCLUSIONSMucolytics reduce exacerbations and hospitalizations in patients with stable COPD and have a safety profile comparable to that of placebo.

01 May 2023·European Food Research and Technology

Study of the metabolism of S-allylmercaptocysteine to elucidate its metabolites and metabolic pathway in rats

Author: Nakamoto, Masato ; Kunimura, Kayo

S-allylmercaptocysteine (SAMC) is one of the characteristic sulfur constituents in aged garlic extract and has been shown to exert various pharmacol. actions.However, because of the short half-life of SAMC, its metabolic profile and mode of action remain largely unclear.We investigated the metabolism of SAMC with the aim to identify its metabolites and metabolic pathway.After i.v. administration of SAMC to rats, the plasma and urine were examined using liquid chromatog.-mass spectrometry (LC-MS) at various time points.The anal. of plasma led us to identify four SAMC metabolites, S-3-hydroxypropylcysteine, S-2-carboxyethylcysteine, S-3-hydroxypropylglutathione and N-acetyl-S-3-hydroxypropylcysteine.The ex vivo and in vitro metabolic studies using rat plasma and S9 fraction from liver or kidney revealed that SAMC was rapidly converted to diallylpolysulfides that are volatile and thus dissipate via lung and skin during circulation.We also found that diallylpolysulfides were further metabolized to glutathione S-conjugates, cysteine S-conjugates, and N-acetylated forms in the metabolic studies.In addition, we identified two N-acetylcysteine S-conjugates, N-acetyl-S-3-hydroxypropylcysteine and N-acetyl-S-2-carboxyethylcysteine in rat urine, the amount of which was estimated to be 10.7% of SAMC being administered.The present findings serve as the key step to elucidate the entire metabolism of SAMC and its mode of pharmacol. action.

100 Deals associated with Fudosteine

External Link

KEGG	Wiki	ATC	Drug Bank
D01845	-	R03	-

R&D Status

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Indication	Country/Location	Organization	Date
Respiratory Diseases	China	Lianyungang Runzhong Pharmaceutical Co., Ltd.	15 Nov 2005
Productive Cough	Japan	Hisamitsu Pharmaceutical Co., Inc.	02 Oct 2001

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