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.

CTR20242711

/ CompletedNot Applicable

评估受试制剂聚普瑞锌口崩片与参比制剂聚普瑞锌口崩片（PromacD）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 to evaluate the test preparation of PromacD orally disintegrating tablets and the reference preparation of PromacD orally disintegrating tablets in healthy adult subjects in the fasting/fed state

研究空腹/餐后状态下单次口服受试制剂聚普瑞锌口崩片与参比制剂聚普瑞锌口崩片（PromacD）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。研究受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The pharmacokinetics of the test preparation, PromacD orally disintegrating zinc tablets, and the reference preparation, PromacD orally disintegrating zinc tablets (PromacD) were studied in healthy subjects after a single oral administration in the fasting/postprandial state, and the bioequivalence of the two preparations was evaluated after oral administration in the fasting/postprandial state. The safety of the test preparation and the reference preparation in healthy subjects was studied.

Start Date14 Aug 2024

Sponsor / Collaborator

Hainan Jinruibao Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Polaprezinc

100 Translational Medicine associated with Polaprezinc

100 Patents (Medical) associated with Polaprezinc

410

Literatures (Medical) associated with Polaprezinc

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 ; Kawaratani, Hideto ; Sawada, Yasuhiko ; Saeki, Keigo ; Nishimura, Norihisa ; Takaya, Hiroaki ; Moriya, Kei

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.

01 Jan 2024·ORL

Efficacy of Normalising Serum Zinc Level for Patients with Olfactory Dysfunction and Zinc Deficiency

Article

Author: Mori, Eri ; Sekine, Rumi ; Tanaka, Hirotaka ; Nagai, Monami ; Otori, Nobuyoshi ; Tei, Masayoshi ; Yonezawa, Nagomi

Introduction: Zinc deficiency may worsen the severity of olfactory dysfunction; however, the relationship between serum zinc levels and therapeutic effects on olfactory dysfunction remains uncertain. This study investigated the relationship between normalising serum zinc levels and the therapeutic effects on olfactory dysfunction. Methods: Forty-two patients diagnosed with post-infectious, post-traumatic, and idiopathic olfactory dysfunction, with serum zinc levels <70 μg/dL, were included in the study. All patients were treated with mecobalamin, tokishakuyakusan, and polaprezinc. The patients were divided into 2 groups: the zinc-normalised (≥70 μg/dL) and zinc-deficient (<70 μg/dL) groups, based on their post-treatment serum zinc levels. Olfactory test results were compared in each of the 2 groups. Results: The patients were treated for a median of 133 days. The zinc-normalised group had significantly better results in all olfactory tests (detection/recognition thresholds of the T&T olfactometer, odour identification test (Open Essence), Visual Analogue Scale for olfactory dysfunction, and self-administered odour questionnaire). In contrast, only the self-administered odour questionnaire showed a significant improvement in the zinc-deficient group, with no significant differences observed in the other olfactory tests. When comparing the changes in the olfactory test scores between the 2 groups, significant differences were observed in the detection/recognition thresholds of the T&T olfactometer test and Open Essence results. Conclusion: These findings suggest that patients with olfactory dysfunction may have difficulty improving their olfactory function if they also have zinc deficiency. Furthermore, normalisation of zinc deficiency may contribute to the improvement of olfactory dysfunction with general treatment.

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Stomach Ulcer	224	Polaprezinc	ghmancsjtv(cjoebirjjy) = rybxnyuwae tzqrtjkucq (pnsjgntnuf ) View more	Negative	12 Aug 2022
				Rebamipide	ghmancsjtv(cjoebirjjy) = ngzzfmfsyi tzqrtjkucq (pnsjgntnuf ) View more
NCT00810368 (CTgov)	Phase 2	Persian Gulf Syndrome	33	Carnosine (Carnosine Treatment Group)	xebbqszdke(ukgxsoknqs) = updghtbspw whvitojbeh (kdzrolljin, sdphkowoag - hogrfrfjoy) View more	-	18 Aug 2016
				Placebo (Placebo Control Group)	xebbqszdke(ukgxsoknqs) = nzvsaeknwp whvitojbeh (kdzrolljin, txwvmjhajj - kehcunnqcg) View more

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