主要试验目的：评价中国健康受试者单次空腹和单次餐后口服宁夏康亚药业股份有限公司持证的艾拉莫德片25 mg（规格：25 mg/片；受试制剂）和海南先声药业有限公司生产的艾拉莫德片25 mg（艾得辛，规格：25 mg/片；参比制剂）的生物等效性；次要试验目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence of a single fasting and postprandial oral administration of 25 mg of Iguratimod tablets (specification: 25 mg/tablet; test preparation) certified by Ningxia Kangya Pharmaceutical Co., Ltd. and 25 mg of Iguratimod tablets (Edixin, specification: 25 mg/tablet; reference preparation) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. in healthy Chinese subjects; Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date27 Jul 2024

Sponsor / Collaborator

Kangya of Ningxia Pharmaceutical Co., Ltd.

CTR20242009 / CompletedNot Applicable

健康受试者空腹及餐后状态下口服比索洛尔氨氯地平片后人体生物等效性试验

[Translation] Bioequivalence study of bisoprolol-amlodipine tablets in healthy subjects after oral administration in fasting and fed state

主要试验目的：在中国健康受试者中评价单次空腹和单次餐后服用宁夏康亚药业股份有限公司生产的比索洛尔氨氯地平片1片（规格：富马酸比索洛尔5 mg与苯磺酸氨氯地平（按氨氯地平计）5 mg；受试制剂）和Merck Kft生产的比索洛尔氨氯地平片1片（商品名：康忻安，规格：富马酸比索洛尔5 mg与苯磺酸氨氯地平（按氨氯地平计） 5 mg；参比制剂）的生物等效性。次要试验目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence of a single fasting and postprandial dose of 1 tablet of bisoprolol amlodipine produced by Ningxia Kangya Pharmaceutical Co., Ltd. (specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine); test preparation) and 1 tablet of bisoprolol amlodipine produced by Merck Kft. (trade name: Kangxinan, specification: 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (calculated as amlodipine); reference preparation) in healthy Chinese subjects. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Jul 2024

Sponsor / Collaborator

Kangya of Ningxia Pharmaceutical Co., Ltd.

CTR20240532 / CompletedNot Applicable

苯磺酸氨氯地平片健康人体生物等效性研究

[Translation] Study on the bioequivalence of amlodipine besylate tablets in healthy volunteers

主要试验目的：在中国健康受试者中单次空腹和单次餐后口服宁夏康亚药业股份有限公司生产的苯磺酸氨氯地平片5mg（规格：5mg/片；受试制剂）和辉瑞制药有限公司生产的苯磺酸氨氯地平片5mg（络活喜，规格：5mg/片；参比制剂）的生物等效性；次要试验目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: To investigate the bioequivalence of a single fasting and postprandial oral administration of 5 mg amlodipine besylate tablets (specification: 5 mg/tablet; test preparation) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and 5 mg amlodipine besylate tablets (Norvasc, specification: 5 mg/tablet; reference preparation) produced by Pfizer Pharmaceuticals Co., Ltd. in healthy Chinese subjects; Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date07 Apr 2024

Sponsor / Collaborator

Kangya of Ningxia Pharmaceutical Co., Ltd.

100 Clinical Results associated with Kangya of Ningxia Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Kangya of Ningxia Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Kangya of Ningxia Pharmaceutical Co., Ltd.

17 Apr 2024·Journal of Agricultural and Food Chemistry

Natural Amino Acid-Bearing Carbamate Prodrugs of Daidzein Increase Water Solubility and Improve Phase II Metabolic Stability for Enhanced Oral Bioavailability

Article

Author: Zhang, Jiaming ; Li, Yingchao ; Zhou, Xiaomian ; Jiang, Qikun ; Li, Huichao ; Zhang, Hui ; Wang, Weiping ; Lu, Farong ; Yang, Miaomiao ; Xu, Youjun ; Ma, Zhining ; Zhang, Yawei ; He, Zhonggui ; Zhang, Tianhong ; Sun, Jin ; Li, Wenchao ; Liu, Xiaoyu

Daidzein (DAN) is an isoflavone, and it is often found in its natural form in soybean and food supplements. DAN has poor bioavailability owing to its extremely low water solubility and first-pass metabolism. Herein, we hypothesized that a bioactivatable natural amino acid-bearing carbamate prodrug strategy could increase the water solubility and metabolic stability of DAN. To test our hypothesis, nine amino acid prodrugs of DAN were designed and synthesized. Compared with DAN, the optimal prodrug (daidzein-4'-O-CO-N-isoleucine, D-4'-I) demonstrated enhanced water solubility and improved phase II metabolic stability and activation to DAN in plasma. In addition, unlike the passive transport of DAN, D-4'-I maintained high permeability via organic anion-transporting polypeptide 2B1 (OATP2B1)-mediated transport. Importantly, D-4'-I increased the oral bioavailability by 15.5-fold, reduced the gender difference, and extended the linear absorption capacity in the pharmacokinetics of DAN in rats. Furthermore, D-4'-I exhibited dose-dependent protection against liver injury. Thus, the natural amino acid-bearing carbamate prodrug strategy shows potential in increasing water solubility and improving phase II metabolic stability to enhance the oral bioavailability of DAN.

01 Jan 2023·Frontiers in chemistry

Simultaneous effect of different chromatographic conditions on the chromatographic retention of pentapeptide derivatives (HGRFG and NPNPT).

Article

Author: Zhao, Jinli ; Yang, Xiangrong ; Zhang, Zhongqi ; Liu, Jianli ; Fang, Huanle ; Peng, Huan ; Zhao, Te ; Li, Yan

Introduction: Oligopeptides exhibit great prospects for clinical application and its separation is of great importance in new drug development. Methods: To accurately predict the retention of pentapeptides with analogous structures in chromatography, the retention times of 57 pentapeptide derivatives in seven buffers at three temperatures and four mobile phase compositions were measured via reversed-phase high-performance liquid chromatography. The parameters ( __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ k H A , __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ k A , and __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__p K a ) of the acid-base equilibrium were obtained by fitting the data corresponding to a sigmoidal function. We then studied the dependence of these parameters on the temperature (T), organic modifier composition (φ, methanol volume fraction), and polarity ( __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ P m N parameter). Finally, we proposed two six-parameter models with (1) pH and T and (2) pH and φ or __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ P m N as the independent variables. These models were validated for their prediction capacities by linearly fitting the predicted retention factor k-value and the experimental k-value. Results: The results showed that __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__log k H A and __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__log k A exhibited linear relationships with __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__1 / T , φ or __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ P m N for all pentapeptides, especially for the acid pentapeptides. In the model of pH and T, the correlation coefficient (R²) of the acid pentapeptides was 0.8603, suggesting a certain prediction capability of chromatographic retention. Moreover, in the model of pH and φ or __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ P m N , the R² values of the acid and neutral pentapeptides were greater than 0.93, and the average root mean squared error was approximately 0.3, indicating that the k-values could be effectively predicted. Discussion: In summary, the two six-parameter models were appropriate to characterize the chromatographic retention of amphoteric compounds, especially the acid or neutral pentapeptides, and could predict the chromatographic retention of pentapeptide compounds.

01 Feb 2018·Drug Delivery and Translational ResearchQ3 · MEDICINE

Ion-pair formation combined with a penetration enhancer as a dual strategy to improve the transdermal delivery of meloxicam

Q3 · MEDICINE

Article

Author: Jiang, Qikun ; Ma, Panqin ; Sun, Yinghua ; Liu, Cuiru ; Wang, Jin ; He, Zhonggui ; Sun, Mengchi

The aim of the study was to develop a novel drug-in-adhesive patch for transdermal delivery of meloxicam (MLX). The formulation involved a strategy to combine a chemical enhancer with an ion-pair agent. Diethylamine (DETA) was selected as the counter ion to form the ion-pair agent MLX-DETA. MLX-DETA was characterized by nuclear magnetic resonance spectroscopy (NMR) and Fourier transform infrared spectroscopy (FTIR). The ion-pair lifetime (T _life) of MLX-DETA was 164.1 μs. The water solubility of MLX-DETA was increased nearly 9.3-fold, compared with that of MLX. Oleic acid (OA) was selected as the chemical enhancer, and the optimized formulation consisted of 5% (w/w) MLX-DETA, 5% (w/w) oleic acid, and DURO-TAK® 87-4098 adhesive as the pressure-sensitive adhesive matrix. The permeation study in vitro showed that both the counter ion and chemical enhancer were effective in improving the skin permeation of MLX. Tissue distribution studies demonstrated that higher accumulation of MLX following application of the MLX-DETA patch to the skin could be obtained in rats compared with the MLX-patch group. In conclusion, to increase the skin absorption and obtain a sustained release for the transdermal delivery of MLX, preparation of a drug-in-adhesive patch by combining an ion pair (MLX-DETA) with a permeation enhancer (OA) is a suitable strategy.

100 Deals associated with Kangya of Ningxia Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Kangya of Ningxia Pharmaceutical Co., Ltd.

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