[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.

CTR20232903 / CompletedPhase 1

评估受试制剂烟台万润药业西洛他唑片50mg与参比制剂美国Teva西洛他唑片50mg作用于健康成年受试者在空腹状态下的单中心、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, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation, Yantai Wanrun Pharmaceutical Cilostazol Tablets 50 mg, and the reference preparation, American Teva Cilostazol Tablets 50 mg, in healthy adult subjects in the fasting state.

研究空腹状态下单次口服受试制剂西洛他唑片（规格：50mg；烟台万润药业有限公司生产）与参比制剂西洛他唑片（规格：50mg；Teva产品）在健康受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。

[Translation]

The pharmacokinetics of a single oral dose of the test preparation, cilostazol tablets (specification: 50 mg; produced by Yantai Wanrun Pharmaceutical Co., Ltd.) and the reference preparation, cilostazol tablets (specification: 50 mg; produced by Teva) in healthy subjects were studied in the fasting state, and the bioequivalence of the two preparations was evaluated.

Start Date11 Oct 2023

Sponsor / Collaborator

Yantai Valiant Pharmaceutical Co., Ltd.

100 Clinical Results associated with Yantai Valiant Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Yantai Valiant Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Yantai Valiant Pharmaceutical Co., Ltd.

15 Jul 2023·Bioorganic & medicinal chemistry

5-(4-Hydroxyphenyl)-3H-1,2-dithiole-3-thione derivatives of brefeldin A: Design, synthesis and cytotoxicity in MDA-MB-231 human breast cancer cells.

Article

Author: Wang, Siyuan ; Hua, Huiming ; Sun, Baojia ; Ye, Tao ; Li, Dahong ; Pan, Huaqi ; Wang, Mingying ; Hou, Yonglian ; Wang, Yanbing

27 novel 5-(4-hydroxyphenyl)-3H-1,2-dithiole-3-thione derivatives of brefeldin A were designed and synthesized to make them more conducive to the cancer treatment. The antiproliferative activity of all the target compounds was tested against six human cancer cell lines and one human normal cell line. Compound 10d exhibited nearly the most potent cytotoxicity with IC₅₀ values of 0.58, 0.69, 1.82, 0.85, 0.75, 0.33 and 1.75 μM against A549, DU-145, A375, HeLa, HepG2, MDA-MB-231 and L-02 cell lines. Moreover, 10d inhibited metastasis and induced apoptosis of MDA-MB-231 cells in a dose-dependent manner. The potent anticancer effects of 10d were prompted based on the aforementioned results, the therapeutic potential of 10d for breast cancer was worth further exploration.

31 Dec 2022·Journal of Enzyme Inhibition and Medicinal Chemistry

Anti-breast cancer sinomenine derivatives via mechanisms of apoptosis induction and metastasis reduction

Article

Author: Gao, Xiang ; Xu, Fanxing ; Sun, Jianan ; Sun, Baojia ; Hua, Huiming ; Li, Dahong ; Hou, Yonglian ; Liu, Lilin

Sinomenine, a morphinane-type isoquinoline-derived alkaloid, was first isolated from stems and roots of Sinomenium diversifolius (Miq.) in 1920. Later discovery by researchers confirmed various essential biological efficacy sinomenine exerted in vitro and in vivo. In this study, a series of 15 sinomenine/furoxan hybrid compounds were designed and synthesised in search of a TNBC drug candidate. Some of the target compounds exhibited strong antiproliferative activities against cancer cell lines, especially for TNBC cells, compared to positive controls. Among them, hybrid 7Cc exerted superior cytotoxic effects on cancer cell lines with exceptionally low IC₅₀ (0.82 μM) against MDA-MB-231 cells with the highest safety index score. Further studies in mechanism displayed that 7Cc could induce an S phase cell cycle arrest, stimulate apoptosis in MDA-MB-231 cells, disrupt mitochondrial membrane potential and exert a genotoxic effect on DNA in cancer cells. In addition, 7Cc also notably inhibited MDA-MB-231 cells in both migration, invasion and adhesion.

01 Nov 2018·Archives of Pharmacal ResearchQ3 · MEDICINE

Bioactive enmein-type 6,7-seco-ent-kaurane diterpenoids: natural products, synthetic derivatives and apoptosis related mechanism

Q3 · MEDICINE

Review

Author: Wang, Mingying ; Sun, Baojia ; Xu, Jinyi ; Xu, Yongnan ; Hua, Huiming ; Hu, Xu ; Gao, Xiang ; Li, Haonan ; Li, Dahong ; Xu, Shengtao

Diterpenoids are important and widely distributed natural compounds with various biological effects, including antitumor, anti-inflammatory and so on. Great efforts have been put in phytochemistry research on diterpenoids. A number of structural modified derivatives and pharmacophore incorporated hybrids were also designed and synthesized with promising therapeutic effects. Among the hopefuls, enmein-type 6,7-seco-ent-kaurane diterpenoids with unique ring system and stereogenic centers exhibit attractive activities. Based on their lead-like properties, enmein-type diterpenoids are suitable for further medicinal study. The derivatives were biologically evaluated and showed promising activities, which warranted in-depth research for further understanding. In this review, the natural bioactive enmein-type diterpenoids and the synthetic derivatives were comprehensively summarized.

100 Deals associated with Yantai Valiant Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Yantai Valiant Pharmaceutical Co., Ltd.

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