[Translation] A single-center, single-dose, two-formulation, two-sequence, four-period, randomized, open-label, completely repeated crossover bioequivalence study of furosemide tablets in Chinese healthy subjects under fed conditions

主要目的：以珠海润都制药股份有限公司生产的呋塞米片（规格：20mg）为受试制剂，Validus Pharmaceuticals LLC生产的呋塞米片（规格：20mg，商品名：LASIX®）为参比制剂，在餐后状态下评价受试制剂和参比制剂在健康受试者中的生物等效性。次要目的：观察餐后状态下受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects in the postprandial state, using furosemide tablets (specification: 20 mg) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. as the test preparation and furosemide tablets (specification: 20 mg, trade name: LASIX®) produced by Validus Pharmaceuticals LLC as the reference preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects in the postprandial state.

Start Date04 Mar 2025

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

CTR20244000

/ CompletedNot Applicable

双氯芬酸钠缓释片人体生物等效性试验

[Translation] Bioequivalence study of diclofenac sodium sustained-release tablets in healthy volunteers

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂双氯芬酸钠缓释片（规格：0.1g，生产厂家：珠海润都制药股份有限公司）与参比制剂双氯芬酸钠缓释片（规格：0.1g，持证商：Novartis Pharma GmbH，商品名：VOLTAREN®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂双氯芬酸钠缓释片和参比制剂双氯芬酸钠缓释片在健康受试者中的安全性。

[Translation]

Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation diclofenac sodium sustained-release tablets (specification: 0.1g, manufacturer: Zhuhai Rundu Pharmaceutical Co., Ltd.) and the reference preparation diclofenac sodium sustained-release tablets (specification: 0.1g, licensee: Novartis Pharma GmbH, trade name: VOLTAREN®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation diclofenac sodium sustained-release tablets and the reference preparation diclofenac sodium sustained-release tablets in healthy subjects.

Start Date01 Nov 2024

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

CTR20244001

/ CompletedNot Applicable

格列齐特片在中国健康受试者中空腹/餐后状态下单中心、随机、开放、单剂量、两制剂、两周期交叉生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of gliclazide tablets in Chinese healthy subjects under fasting/fed conditions

主要目的：以珠海润都制药股份有限公司生产的格列齐特片（规格：40 mg）为受试制剂，以 Dainippon Sumitomo Pharma Co., Ltd.持证的格列齐特片（商品名：Glimicron®，规格：40mg）为参比制剂，在空腹/餐后状态下考察两制剂在健康受试者中的生物等效性。次要目的：观察口服受试制剂格列齐特片（规格：40mg）和参比制剂格列齐特片（商品名：Glimicron®，规格：40mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the bioequivalence of the two preparations in healthy subjects in the fasting/postprandial state, using gliclazide tablets (specification: 40 mg) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. as the test preparation and gliclazide tablets (trade name: Glimicron®, specification: 40 mg) certified by Dainippon Sumitomo Pharma Co., Ltd. as the reference preparation. Secondary objective: To observe the safety of oral test preparation gliclazide tablets (specification: 40 mg) and reference preparation gliclazide tablets (trade name: Glimicron®, specification: 40 mg) in healthy subjects in China.

Start Date31 Oct 2024

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhuhai Rundu Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Zhuhai Rundu Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Zhuhai Rundu Pharmaceutical Co., Ltd.

01 Feb 2024·Russian Journal of Coordination Chemistry

Syntheses, Crystal Structure, and Properties of Two New Coordination Polymers from a Triphenylamino-Based Ligand

Author: Tang, W. B. ; Cai, Q. ; Su, J. ; You, X. H.

Abstract: Two new coordination polymers, namely, {[CdCl₂(BIPAB)₂]·H₂O}_n (I) (BIPAB = 4-(bis(4-(1H-imidazol-1-yl)phenyl)amino)benzonitrile) and {[NiCl₂(HBIPABA)₂]·2H₂O}_n (II) (HBIPABA = 4-(bis(4-(1H-imidazol-1-yl)phenyl)amino)benzoic acid), have been successfully synthesized by using a triphenylamino-based ligand BIPAB, as original reactant and characterized by single-crystal X-ray diffraction, elemental anal., IR spectroscopy, TG, and luminescence.X-ray single crystal diffraction anal. (CCDC numbers 2283736 and 2283737 for I and II, resp.) shows that both compounds I and II crystallize in monoclinic crystal system with space groups are P2/c and P2₁, resp.All of them exhibit one-dimensional (1D) ribbon coordination chain formula as [MCl₂(L)₂]_n.However, the 1D chains were packing into different three-dimensional (3D) supramol. frameworks mainly due to the uncoordinated addnl. functional groups on the ligand.For compound I, the 1D chains cross arrange to form a 3D supermol. framework, in which the nitrile grouping showed as guest mol. to be accommodated by Cd₂L₂ ring on adjacent 1D chains; for compound II, the 1D chains were connected by the hydrogen bonds between in situ formed carboxyl groups to formed a two-dimensional (2D) hydrogen bonding network, and the 2D networks were further interpenetrated to forms a 3D supermol. framework.Compounds I and II showed a thermal stability up to 380 and 280°C, resp.Moreover, compound I exhibits an intense blue emission centered at 490 nm upon excitation at 370 nm.

01 Nov 2021·Bioorganic & Medicinal Chemistry LettersQ4 · MEDICINE

Novel carbohydrate-based sulfonamide derivatives as selective carbonic anhydrase II inhibitors: Synthesis, biological and molecular docking analysis

Q4 · MEDICINE

Article

Author: Cai, Qiang ; Cheng, Mao-Sheng ; Hou, Zhuang

A series of sulfonamides containing glucosamine moieties had been prepared and investigated for the inhibition of the zinc enzyme carbonic anhydrases (CAs, EC 4.2.1.1). Compared to their parent compound p-sulfamoylbenzoic acid, target compounds showed two order of magnitude improvement in their binding affinities against hCA II in vitro. Moreover, they also showed great selectivity toward hCA II enzyme with the ratios for inhibiting hCA II over hCA I in the range 20-96 and for inhibiting hCA II over hCA IX in the range 4.3-9. Due to the introduction of glucosamine moieties, all of compounds displayed good water solubility (in the range of 2.0-2.5%) and the pH values of the obtained solutions is neutral (7.0-7.2). Compared to the clinically available and relatively highly acidic dorzolamide (pH 5.5), target compounds are more likely to be less irritating to the eye when applied to topical glaucomatous drugs. Then, cytotoxicity evaluation suggested that all target compounds did not display any appreciable toxicity against human cornea epithelial cell. In addition, molecular docking studies elucidated the binding modes of those compounds toward hCA II. Collectively, these results suggest that target compounds represented a promising scaffold to treat glaucoma without major topical side effects.

Yiyao Daobao

Bioequivalence Study of Ibuprofen Sustained Release Capsules in Chinese Healthy Subjects

Author: Liu Jie ; Yang Qiong ; Chen Xinmin ; Yang Peixin ; Xie Bin

Objective To evaluate the bioequivalence of ibuprofen sustained release capsules(300 mg) in Chinese healthy subjects.Methods A randomized, open-label, single-center, single-dose, two-preparation, two-period, two-sequence, and self-crossover bioequivalence trial was performed in Chinese healthy volunteers.Both fasting and fed trials enrolled 24 healthy subjects.A single dose of test or reference ibuprofen sustained release capsules(300 mg) was administered under fasting or fed conditions per period with 7-day washout period.The concentration of ibuprofen in plasma was determined by HPLC-MS/MS, which was used to evalute the bioequivalence of the two preparationsResults The main pharmacokinetic parameters under fasting conditions for the test and the reference sustained release capsules were as follows: C_(max) were(13 603.75±3 606.48) vs.(14 051.25±2 876.49) ng·mL∼(-1);AUC_(0-t) were(98 846.34±22 299.01) vs.(99 836.30±19 621.61) h·ng·mL∼(-1);AUC_(0-∞ )were(103 207.00±23 890.57) vs.(103 524.09± 22 292.75) h·ng·mL∼(-1);t_(max) were 4.5 vs.4.5 h; t_(1/2) were(4.32±1.92) vs.(4.10±1.23) h.The main pharmacokinetic parameters under fed conditions for the test and the reference sustained release capsules were as follows: C_(max) were(20 552.17±5 320.53) vs.(19 170.83±2 945.22) ng·mL∼(-1);AUC_(0-t) were(102 412.31±19 314.50) vs.(101 928.24±21 749.75) h·ng·mL∼(-1);AUC_(0-∞) were(102 979.26±19 583.29) vs.(102 549.36±22 126.08) h·ng·mL∼(-1);t_(max) were 4.5 vs.4.5 h; t_(1/2) were(2.97±0.34) vs.(2.92±0.36) h.Under fasting conditions, the 90% confidence intervals of C_(max), AUC_(0-t) and AUC_(0-∞) geometric mean ratios were(89.86%, 102.08%), (94.05%, 103.40%) and(94.35%, 104.72%).Under fed conditions, the 90% confidence intervals of C_(max), AUC_(0-t) and AUC_(0-∞) geometric mean ratios were(97.43%, 112.29%), (95.44%, 103.59%) and(95.32%, 103.62%).Conclusion It could therefore be concluded that the test preparation of ibuprofen sustained release capsules was bioequivalent to that of reference

100 Deals associated with Zhuhai Rundu Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Zhuhai Rundu Pharmaceutical Co., Ltd.

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