[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 / RecruitingNot 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.

CTR20231174 / CompletedNot Applicable

评估受试制剂聚普瑞锌颗粒（规格：0.5 g:75 mg）与参比制剂（Promac®）（规格：0.5 g:75 mg）在健康成年受试者空腹和餐后状态下的单中心、随机、开放、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of polyprezinc granules (strength: 0.5 g: 75 mg) and the reference formulation (Promac®) (strength: 0.5 g: 75 mg) in healthy adult subjects in the fasting and fed state.

主要研究目的：研究空腹和餐后状态下单次口服受试制剂聚普瑞锌颗粒（规格：0.5 g:75 mg，持证商：吉林省博大伟业制药有限公司）与参比制剂聚普瑞锌颗粒（Promac®，规格：0.5 g:75 mg，持证商：ゼリア新薬工業株式会社）在健康受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。

[Translation]

Main research purpose: To study the single oral administration of the test preparation Polyprex zinc granules (specification: 0.5 g: 75 mg, license holder: Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation Juprex Pharmacokinetics of zinc granules (Promac®, specifications: 0.5 g: 75 mg, licensee: Seiko Shinsui Industrial Co., Ltd.) in healthy subjects, and evaluation of the bioequivalence of two oral formulations in fasting and postprandial states sex.

Start Date18 May 2023

Sponsor / Collaborator

Jilin Boda Weiye Pharmaceutical Co. Ltd.

100 Clinical Results associated with Polaprezinc

100 Translational Medicine associated with Polaprezinc

100 Patents (Medical) associated with Polaprezinc

541

Literatures (Medical) associated with Polaprezinc

01 Jan 2025·Current Medicinal Chemistry

The Possible Roles of β-alanine and L-carnosine in Anti-aging

Article

Author: Gasmi, Amin ; Mujawdiya, Pavan Kumar ; Smetanina, Kateryna ; Piscopo, Salva ; Résimont, Stéphane ; Beley, Nataliya ; Shanaida, Mariia ; Bjørklund, Geir ; Shanaida, Volodymyr ; Peana, Massimiliano ; Lysiuk, Roman ; Dzyha, Svitlana

β-alanine (BA), being a non-proteinogenic amino acid, is an important constituent of L-carnosine (LC), which is necessary for maintaining the muscle buffering capacity and preventing a loss of muscle mass associated with aging effects. BA is also very important for normal human metabolism due to the formation of a part of pantothenate, which is incorporated into coenzyme A. BA is synthesized in the liver, and its combination with histidine results in the formation of LC, which accumulates in the muscles and brain tissues and has a well-defined physiological role as a good buffer for the pH range of muscles that caused its rapidly increased popularity as ergogenic support to sports performance. The main antioxidant mechanisms of LC include reactive oxygen species (ROS) scavenging and chelation of metal ions. With age, the buffering capacity of muscles also declines due to reduced concentration of LC and sarcopenia. Moreover, LC acts as an antiglycation agent, ultimately reducing the development of degenerative diseases. LC has an anti-inflammatory effect in autoimmune diseases such as osteoarthritis. As histidine is always present in the human body in higher concentrations than BA, humans have to get BA from dietary sources to support the required amount of this critical constituent to supply the necessary amount of LC synthesis. Also, BA has other beneficial effects, such as preventing skin aging and intestinal damage, improving the stress-- fighting capability of the muscle cells, and managing an age-related decline in memory and learning. In this review, the results of a detailed analysis of the role and various beneficial properties of BA and LC from the anti-aging perspective are presented.

01 May 2024·Photochemistry and Photobiology

Evaluation of human skin response to solar‐simulated radiation in an ex vivo model: Effects and photoprotection of L‐Carnosine

Article

Author: Girardi, Cristina ; Benato, Francesca ; Massironi, Michele ; Stuhlmann, Dominik ; Massironi, Marco ; Vindigni, Vincenzo

AbstractSunlight, and more specifically the UV component, induces several skin damages, including sunburns, erythema and photoaging. The purpose of this work is to set up an ex vivo human skin model to assess the capacity of active principles in protecting skin from the deleterious effects of solar radiation. Ex vivo human skin biopsies were cultured in an air–liquid interface and exposed to solar‐simulated radiation (SSR, 300–750 nm). L‐Carnosine (0.2% and 2%) was applied topically to be tested as photoprotective compound. The effect on oxidative stress induction, photoaging and skin transcriptional profile was assessed by evaluating reactive oxygen species, advanced glycosylation end products formation and gene expression changes. In our model, SSR increases ROS production and AGE accumulation and affects the expression of genes related to oxidative stress, pigmentation, immunity, inflammation and photoaging. Among these pathways, 11 genes were selected as biomarkers to evaluate the skin solar radiation response. Results showed that L‐Carnosine provides effective prevention against solar radiation damages reducing ROS, AGEs and mitigating the modulation of the selected biomarker genes. In conclusion, we report that our ex vivo skin model is a valuable system to assess the consequences of solar light exposure and the capacity of topically applied L‐Carnosine to counteract them.

01 Apr 2024·International Journal of Pharmaceutics

Magnetic Lipid-Based hybrid nanosystems: A combined stimuli- responsive nanocarriers for enriched chemotherapeutic potential of L-carnosine in induced breast Ehrlich ascites tumor model

Article

Author: AbouKilila, HussamElDin Y ; Farid, Ragwa M ; Helmy, Maged W ; Hazzah, Heba A ; Abdallah, Ossama Y ; M E Gaafar, Passent

Magnetic Lipid-Based Hybrid Nanosystems (M-LC_NPs) is a novel nanoplatform that can respond to magnetic stimulus and are designed for delivering L-carnosine (CN), a challenging dipeptide employed in the treatment of breast cancer. CN exhibits considerable water solubility and undergoes in-vivo degradation, hence restricting its application. Consequently, it is anticipated that the developed M-LC_NPs will enhance the effectiveness of CN. To ensure the physical stability of MNPs, they were initially coated with a mixture of oleic acid and oleylamine before being included in pegylated liquid crystalline nanoparticles (PLCNPs). The proposed M-LC_NPs exhibited promising in-vitro characteristics, notably a small particle size (143.5 nm ± 1.25) and a high zeta potential (-39.5 mV ± 1.54), together with superparamagnetic behavior. The in-vitro release profile exhibited a prolonged release pattern. The IC₅₀ values of M-LC_NPs were 1.57 and 1.59 times lower than these of the CN solution after 24 and 48 hours, respectively. Female BALB/C female mice with an induced breast cancer (Ehrlich Ascites tumor [EAT] model) were used to study the influence of an external magnetic field on the chemotherapeutic activity and toxicity of CN loaded in the developed M-LC_NPs. Stimuli-responsive M-LCNPs exhibited no apparent systemic toxicity in addition to enhanced chemotherapeutic efficacy compared to nontargeted M-LC_NPs and CN solution, as evidenced by a reduction of % tumor growth (11.7%), VEGF levels (22.95 pg/g tissue), and cyclin D1 levels (27.61 ng/g tissue), and an increase in caspase-3 level (28.9 ng/g tissue). Ultimately, the developed stimuli-responsive CN loaded M-LC_NPs presented a promising nanoplatform for breast cancer therapy.

News (Medical) associated with Polaprezinc

26 Oct 2023

·www.prnewswire.com

Serious Concerns About Frequent Heartburn Medications Spurs Demand for Healthy Alternatives

-Enzymedica Offers All-Natural Relief- VENICE, Fla., Oct. 26, 2023 /PRNewswire/ -- As consumer interest in heartburn solutions reaches unprecedented levels, Enzymedica, a trusted leader in digestive health, introduces a range of all-natural, healthy alternatives for occasional heartburn and indigestion relief. This move comes in response to the recent revelation of a study linking long-term usage of Proton Pump Inhibitors (PPIs) to potential health risks, including dementia. With a commitment to providing safe and effective solutions, Enzymedica offers consumers a variety of options that not only relieve symptoms of occasional heartburn resulting from food and diet choices, but also promote overall digestive wellness. Continue Reading Concerns about heartburn medication spurs demand for healthy alternatives for occasional heartburn relief like Enzymedica's Heartburn Soothe. (PRNewsfoto/Enzymedica) The heartburn solutions category has faced stagnation due to a lack of innovation, concerns about drug side effects and confusion surrounding the frequent, long-term usage of PPIs and other acid inhibitors. The recent study shedding light on potential health risks associated with PPIs has left consumers seeking trustworthy alternatives that prioritize their well-being. Not only do Enzymedica's range of heartburn relief products, including Heartburn Soothe, Acid Soothe and Betaine HCI, offer instant relief from occasional heartburn and indigestion, but they also contribute to the rebuilding of the gastrointestinal lining and promote long-term digestive health. "It is disheartening and concerning to hear about the results of this latest study linking heartburn medications and dementia, especially considering there are so many people using them on a long-term basis - far longer than indicated. The good news is that there are all-natural, safe solutions to help people with occasional indigestion and heartburn," says Ryan Sensenbrenner, senior director of marketing at Enzymedica. "In addition to food, diet and lifestyle choices, some great suggestions for relieving occasional heartburn include looking for products that include betaine, zinc carnosine and/or alginate, like Enzymedica's entire suite of products indicated to provide instant relief to soothe and protect the digestive system." Enzymedica products are available for purchase on their official website, Enzymedica.com, as well as Amazon.com and at various retail locations such as Whole Foods, Sprouts, Fresh Thyme and CVS. These products offer consumers a reliable and convenient way to address their occasional heartburn concerns with natural, science-backed solutions. About Enzymedica: Enzymedica is a trusted leader in the field of digestive health, committed to providing natural, effective solutions for various digestive concerns. With a focus on innovation and science-backed formulations, Enzymedica offers consumers a wide range of products that promote optimal digestive wellness. Disclaimer: The statements made in this press release have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Media Contact Anjie Oberholzer (484) 241-6926 [email protected] SOURCE Enzymedica

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	JP	Zeria Pharmaceutical Co., Ltd.	06 Oct 1994

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Stomach Ulcer	224	Polaprezinc	uvqhvqmtgs(ndngjnfpns) = hdqdpnmvsg jbgxwdncwk (rwifakjlua ) View more	Negative	12 Aug 2022
				Rebamipide	uvqhvqmtgs(ndngjnfpns) = wcxscltyix jbgxwdncwk (rwifakjlua ) View more
NCT00810368 (CTgov)	Phase 2	Persian Gulf Syndrome	33	Carnosine (Carnosine Treatment Group)	ocabbsibgc(kiifnfhgkf) = gjxebtyair mkjdeqslkr (tbnxtufgtj, uwhbxswwfq - opklmbsoja) View more	-	18 Aug 2016
				Placebo (Placebo Control Group)	ocabbsibgc(kiifnfhgkf) = lrtmfumxva mkjdeqslkr (tbnxtufgtj, mvxzbkfnqh - vykzebxalg) View more

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