本试验旨在研究空腹和餐后状态下单次口服受试制剂T聚普瑞锌口腔崩解片（规格：75 mg）与参比制剂R聚普瑞锌口腔崩解片（规格：75 mg；商品名：Promac® D）的药代动力学特征，比较受试制剂与参比制剂在健康研究参与者体内吸收速度和程度的差异，同时评价空腹试验中聚普瑞锌口腔崩解片在中国健康参与者中的适口性，为聚普瑞锌口腔崩解片用药口感提供依据。

[Translation]

The purpose of this study was to investigate the pharmacokinetic characteristics of a single oral administration of the test formulation T polypreg zinc orally disintegrating tablets (strength: 75 mg) and the reference formulation R polypreg zinc orally disintegrating tablets (strength: 75 mg; trade name: Promac® D) in the fasting and fed states, to compare the differences in absorption rate and extent between the test formulation and the reference formulation in healthy study participants, and to evaluate the palatability of polypreg zinc orally disintegrating tablets in healthy Chinese participants in the fasting study, so as to provide a basis for the taste of polypreg zinc orally disintegrating tablets.

Start Date12 Mar 2025

Sponsor / Collaborator

China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.

CTR20244758

/ CompletedNot Applicable

聚普瑞锌颗粒健康人体生物等效性研究

[Translation] Study on the bioequivalence of polyprezinc granules in healthy volunteers

主要目的：本研究以福建海西新药创制股份有限公司研发的聚普瑞锌颗粒（规格：75mg）为受试制剂，按生物等效性研究的有关规定，以原研厂家ゼリア新薬工業株式会社生产的聚普瑞锌颗粒（规格：75mg（150mg/g×0.5g/包），商品名：Promac®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂聚普瑞锌颗粒和参比制剂聚普瑞锌颗粒（商品名：Promac®）在健康受试者中的安全性。

[Translation]

Main purpose: This study uses Polyprezine Granules (specification: 75 mg) developed by Fujian Haixi New Drug Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, it is produced by the original manufacturer, Riya New Pharmaceutical Co., Ltd. Polyprezinc granules (specification: 75 mg (150 mg/g × 0.5 g/pack), trade name: Promac®) are reference preparations. After administration of the test preparation and reference preparation under fasting/postprandial conditions, of bioequivalence. Secondary purpose: To observe the safety of the test preparation Polyprezinc Granules and the reference preparation Polyprezinc Granules (trade name: Promac®) in healthy subjects.

Start Date26 Dec 2024

Sponsor / Collaborator

Fujian Haixi New Drug Creation Co., Ltd.

CTR20243088

/ CompletedNot Applicable

评估受试制剂聚普瑞锌颗粒与参比制剂聚普瑞锌颗粒（Promac®）作用于健康成年受试者在空腹/餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究。

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test formulation of polyprednisolone zinc granules and the reference formulation of polyprednisolone zinc granules (Promac®) in healthy adult subjects under fasting/fed conditions.

研究空腹/餐后状态下单次口服受试制剂聚普瑞锌颗粒与参比制剂聚普瑞锌颗粒（Promac®）在健康成年受试者体内的药代动力学，评价空腹/餐后状态下口服两种制剂的生物等效性。次要研究目的：研究受试制剂聚普瑞锌颗粒和参比制剂“Promac®”在健康受试者中的安全性。

[Translation]

To study the pharmacokinetics of the test preparation of polyprezinc granules and the reference preparation of polyprezinc granules (Promac®) in healthy adult subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting/postprandial state. Secondary study objectives: To study the safety of the test preparation of polyprezinc granules and the reference preparation "Promac®" in healthy subjects.

Start Date17 Sep 2024

Sponsor / Collaborator

Yantai Valiant Pharmaceutical Co., Ltd.

100 Clinical Results associated with Polaprezinc

100 Translational Medicine associated with Polaprezinc

100 Patents (Medical) associated with Polaprezinc

402

Literatures (Medical) associated with Polaprezinc

01 Jun 2025·European Journal of Pharmaceutics and Biopharmaceutics

Development of mucoadhesive films with high polaprezinc content for oral mucositis: A study on formulation and near-infrared spectroscopy-based quality control

Article

Author: Tahara, Kohei ; Yamazoe, Eriko ; Ito, Takaaki ; Ito, Takuya ; Suzuki, Akio ; Funato, Miyui

Polaprezinc (PLZ) has drawn attention to its potential to prevent oral mucositis caused by chemotherapy and radiotherapy. PLZ-containing lozenges have been developed in previous reports; however, for patients with mucositis, taking them may be challenging because of pain. Therefore, this study aimed to develop a mucoadhesive film containing the same amount (18.75 mg) of PLZ as a lozenge as a new dosage form to replace lozenges and evaluate its characteristics. First, various films were created using solvent casting to screen polymers with high PLZ content. Thus, hydroxypropyl cellulose (HPC) was selected; however, film curvature and reduced flexibility necessitated formulation optimization. The optimized films exhibited excellent content uniformity, stability, and mucoadhesive properties, with no significant changes in the drug content after storage. Furthermore, the possibility of using portable near-infrared spectroscopy (Micro NIR™) for the quality control of PLZ films was investigated. Multivariate analysis revealed that the Micro NIR calibration model predicted drug concentrations comparable to those measured by high-performance liquid chromatography. These results suggest that a mucoadhesive film with high PLZ content has been developed and that efficient quality control is possible using Micro NIR™.

01 Feb 2024·Auris Nasus Larynx

Diagnosis and treatment of taste disorders in Japan

Review

Author: Tsuzuki, Kenzo ; Nin, Tomomi

Though 270,000 patients with complaints of taste abnormalities visited medical institutions annually in 2019 survey, there are no drugs for the treatment of taste disorders that are covered by health insurance in Japan. In the survey, the number of patients with taste disorders was correlated with age, and the need for medical treatment for taste disorders is expected to increase in the future because of the super-aging society. The pathophysiology of taste disorders varies widely. There is an obvious need to decide the site and the causes of the disorder and understand the mechanism, by performing various examinations. It needs to first adjust the causative systemic diseases and medications in the treatment for taste disorder. Damage of taste cells due to zinc deficiency is the main pathophysiological mechanism of taste disorders, and zinc supplementation is a standard treatment in Japan. Oral zinc therapy is the treatment for taste disorders due to zinc deficiency or idiopathic taste disorder; though a double-blind study was conducted, it was considered low-level evidence in a clinical review. In Japan, the off-label use of polaprezinc for taste disorders was approved in 2011, and zinc acetate hydrate was approved for hypozincemia in March 2017, making it easier to use oral zinc therapy in general. In some cases, psychotherapy or herbal medicine therapy has been used with remarkable success, although its effectiveness has not been clearly tested. It might be expected to offer some help to patients. In the treatment of elderly patients with taste disorders, physicians need to consider the difference between "age-related changes in taste in healthy people" and "taste disorders in elderly persons", and they should separate them. Aggressive treatment is desirable regardless of age, because no significant difference in the efficacy of various treatments was found between patients older and younger than 65 years.

15 Jan 2024·Internal Medicine

Zinc Supplementation and an Improved Quality of Life in Patients with Autoimmune Hepatitis

Article

Author: Sato, Shinya ; Akahane, Takemi ; Kaji, Kosuke ; Namisaki, Tadashi ; Yoshiji, Hitoshi ; Sawada, Yasuhiko ; Nishimura, Norihisa ; Saeki, Keigo ; Kawaratani, Hideto ; Moriya, Kei ; Takaya, Hiroaki

Objecive Patients with autoimmune hepatitis (AIH) reportedly have an impaired quality of life (QOL), mainly due to depression, even during remission. In addition, hypozincaemia has been demonstrated in patients with chronic liver disease, including AIH, and is known to be related to depression. Corticosteroids are known to cause mental instability. We therefore investigated the longitudinal association between zinc supplementation and changes in the mental status among AIH patients treated with corticosteroids. Materials This study enrolled 26 patients with serological remission of AIH routinely treated at our facility after excluding 15 patients who either discontinued polaprezinc (150 mg/day) within 24 months or interrupted treatment. Two questionnaires, the Chronic Liver Disease Questionnaire (CLDQ) and SF-36, were adopted to evaluate the QOL before and after zinc supplementation. Results Serum zinc levels were significantly elevated after zinc supplementation (p<0.0001). The CLDQ worry subscale significantly improved after zinc supplementation (p=0.017), but none of the SF-36 subscales was affected. Multivariate analyses demonstrated that daily prednisolone dosing was inversely related to both the CLDQ worry domain score (p=0.036) and the SF-36 mental health component (p=0.031). There was a significant negative correlation between the changes in the daily steroid dose and the CLDQ worry domain scores before and after zinc supplementation (p=0.006). No serious adverse events occurred during the observation period. Conclusion Zinc supplementation safely and efficiently improved mental impairment, possibly caused by continuous treatment with corticosteroids, in patients with AIH.

100 Deals associated with Polaprezinc

External Link

KEGG	Wiki	ATC	Drug Bank
D01611	Polaprezinc	A02B	DB09221

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Stomach Ulcer	Japan	Zeria Pharmaceutical Co., Ltd.	06 Oct 1994

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Stomach Ulcer	224	Polaprezinc	wpqyzizkui(vsibpttptz) = ltmejcsnmf kpiyyihvjy (wbwonsiljm ) View more	Negative	12 Aug 2022
				Rebamipide	wpqyzizkui(vsibpttptz) = wygnlsfckm kpiyyihvjy (wbwonsiljm ) View more
NCT00810368 (CTgov)	Phase 2	Persian Gulf Syndrome	33	Carnosine (Carnosine Treatment Group)	jrhpkcojrx(tkbxxhmgyp) = yhcjukzcec vtuhiltyrr (lvbpnobxat, zcoarsqqbx - hxbaclfqte) View more	-	18 Aug 2016
				Placebo (Placebo Control Group)	jrhpkcojrx(tkbxxhmgyp) = lvywjbkght vtuhiltyrr (lvbpnobxat, orvwkspitg - suwzpzjdwp) View more

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