[Translation] A randomized, double-blind, double-dummy, multicenter phase III clinical study on the efficacy and safety of Olmesartan Medoxomil Levoamlodipine Tablets (20mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by Olmesartan Medoxomil Tablets (20mg) or Amlodipine Besylate Tablets (5mg) for 4 weeks

验证复方制剂相对于单方制剂的优效性：评价奥美沙坦酯左氨氯地平片(20mg/2.5mg)用于奥美沙坦酯片(20mg)或苯磺酸氨氯地平片(5mg)单药治疗4周血压不能有效控制的原发性轻、中度高血压患者的有效性和安全性。

[Translation]

To verify the superiority of the combination preparation over the single preparation: To evaluate the efficacy and safety of Olmesartan Medoxomil Levoamlodipine Tablets (20mg/2.5mg) in patients with primary mild to moderate hypertension whose blood pressure cannot be effectively controlled by Olmesartan Medoxomil Tablets (20mg) or Amlodipine Besylate Tablets (5mg) for 4 weeks of monotherapy.

Start Date13 Sep 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20242179 / CompletedNot Applicable

健康成年受试者空腹和餐后单次口服奥美沙坦酯氨氯地平片的随机、开放、单剂量、两序列、两制剂、两周期、双交叉设计的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-formulation, two-period, double-crossover bioequivalence study of fasting and fed single oral administration of olmesartan medoxomil and amlodipine tablets in healthy adult subjects

主要研究目的：研究空腹和餐后状态下单次口服受试制剂奥美沙坦酯氨氯地平片（规格：奥美沙坦酯20mg/苯磺酸氨氯地平5mg（以氨氯地平计），裕松源药业有限公司生产）与参比制剂奥美沙坦酯氨氯地平片（规格：奥美沙坦酯20mg/苯磺酸氨氯地平5mg（以氨氯地平计），第一三共制药（上海）有限公司生产）在健康成年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。次要研究目的：评价健康成年受试者在空腹和餐后状态下，单次口服奥美沙坦酯氨氯地平片受试制剂和参比制剂后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation Olmesartan medoxomil amlodipine tablets (specifications: Olmesartan medoxomil 20mg/amlodipine besylate 5mg (calculated as amlodipine), produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation Olmesartan medoxomil amlodipine tablets (specifications: Olmesartan medoxomil 20mg/amlodipine besylate 5mg (calculated as amlodipine), produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To evaluate the safety of the test preparation and reference preparation of Olmesartan medoxomil amlodipine tablets in healthy adult subjects after a single oral administration in the fasting and fed state.

Start Date05 Jul 2024

Sponsor / Collaborator

Yusongyuan Pharmaceutical Co. Ltd.

CTR20231502 / CompletedNot Applicable

山西德元堂药业有限公司研制的奥美沙坦酯氨氯地平片（规格：40 mg/10 mg）与持证商为Daiichi Sankyo，生产企业为Daiichi Sankyo Europe GmbH的奥美沙坦酯氨氯地平片（规格：40 mg/10 mg；商品名：Sevikar®）在中国健康受试者中进行的单中心、随机、开放、两制剂、空腹/餐后、单次给药、两周期、双交叉设计的生物等效性研究

[Translation] A single-center, randomized, open-label, two-dose, fasting/postprandial, single-dose, two-period, double-crossover bioequivalence study was conducted in healthy Chinese subjects between Olmesartan Medoxomil Amlodipine Tablets (Specification: 40 mg/10 mg) developed by Shanxi Deyuantang Pharmaceutical Co., Ltd. and Olmesartan Medoxomil Amlodipine Tablets (Specification: 40 mg/10 mg; Trade Name: Sevikar®) whose licensee is Daiichi Sankyo and manufacturer is Daiichi Sankyo Europe GmbH.

以山西德元堂药业有限公司研制的奥美沙坦酯氨氯地平片（规格：40 mg/10 mg）为受试制剂，以持证商为Daiichi Sankyo，生产企业为Daiichi Sankyo Europe GmbH的奥美沙坦酯氨氯地平片（规格：40 mg/10 mg；商品名：Sevikar®）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Olmesartan medoxomil amlodipine tablets (specification: 40 mg/10 mg) developed by Shanxi Deyuantang Pharmaceutical Co., Ltd. were used as the test preparation, and Olmesartan medoxomil amlodipine tablets (specification: 40 mg/10 mg; trade name: Sevikar®) produced by Daiichi Sankyo Europe GmbH, the licensee, were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date13 Jun 2023

Sponsor / Collaborator

Shanxi Deyuantang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Amlodipine Besylate/Olmesartan Medoxomil

100 Translational Medicine associated with Amlodipine Besylate/Olmesartan Medoxomil

100 Patents (Medical) associated with Amlodipine Besylate/Olmesartan Medoxomil

Literatures (Medical) associated with Amlodipine Besylate/Olmesartan Medoxomil

12 Dec 2023·ACS Nano

Azo Reductase Activated Magnetic Resonance Tuning Probe with “Switch-On” Property for Specific and Sensitive Tumor Imaging in Vivo

Article

Author: Li, Yu ; Li, Linyao ; Song, Yang ; Song, Erqun ; Zhu, Xiaokang ; Tan, Weihong ; Gu, Peilin ; Deng, Siyu

Cancer remains a threat to human health. However, if tumors can be detected in the early stage, then the effectiveness of cancer treatment could be significantly improved. Therefore, it is worthwhile to develop more sensitive and accurate cancer diagnostic methods. Herein, we demonstrated an azo reductase (AzoR)-activated magnetic resonance tuning (MRET) probe with a "switch-on" property for specific and sensitive tumor imaging in vivo. Specifically, Gd-labeled DNA₁ (DNA₁-Gd) and cyclodextrin-coated magnetic nanoparticles (MNP-CD) were employed as enhancer and quencher of MRET, respectively, while DNA₂, an azobenzene (Azo) group-modified aptamer (AS1411), served as a linker between enhancer and quencher to construct the MRET probe of MNP@DNA_(1-2)-Gd. In tumor tissues with high-level AzoR, the T₁-weighted magnetic resonance signal of the MRET probe could be restored by intelligently regulating the switch from "OFF" to "ON" after activation with AzoR, thus accurately indicating the location of the tumor accurately. Moreover, the tumor with a 4 times smaller size than that of the normal tumor model could be imaged based on the proposed MRET probe. The as-proposed MRET-based magnetic resonance imaging strategy not only achieves tumor imaging accurately but also shows promise for early diagnosis of tumors, which might improve patients' survival rates and provide an opportunity for image-guided biomedical applications in the future.

01 Dec 2023·Biomedicine & Pharmacotherapy

The enhancement effect of small molecule Lyb24 reveals AzoR as a novel target of polymyxin B

Article

Author: Zhao, Yan ; Zhang, Jinyong ; Cheng, Shumin ; Zou, Quanming ; Zeng, Huan ; Huang, Wei ; Wang, Xiao ; Liu, Jianhua ; Li, Jingli ; Cui, Ruiqin ; Sun, Longqin ; Hu, Chunxia ; Huang, Ying ; Zhou, Guibao ; Liu, Shiyi

Given the important role of polymyxin B (PB) in the treatment of drug-resistant Gram-negative bacterial infections, the emergence of PB resistance poses a serious threat to public health. Adjuvant development is a supplementary strategy that can compensate for the lack of novel antibiotics by protecting PB. In this study, we found a small molecule named Lyb24 that showed weak antibacterial activity (minimum inhibitory concentration ≥ 10 μg/ml) but potentiated and revitalized the efficacy of PB against Gram-negative pathogens, including mcr-1- and mgrB-deletion-mediated PB-resistant strains. Our results showed that Lyb24 inhibits the translational levels of genes associated with the modification of lipid A. In addition, Lyb24 increases the permeability, disrupts the integrity and induces the depolarization of the membrane. We further found that both Lyb24 and PB could directly bind to AzoR and inhibit its activity. Structural analysis showed that Lyb24 binds to the isoalloxazine ring of flavin mononucleotide (FMN) through pi-pi stacking and loop η4 of AzoR. A pneumonia model was used to confirm that the activity against clinical PB-resistant Klebsiella pneumoniae was enhanced due to Lyb24 on PB. In conclusion, we provide a potential therapeutic regimen by combining Lyb24 and PB to treat Gram-negative-resistant bacterial infections. Our findings not only explain the synergistic effect of Lyb24, but also expand our knowledge on the mechanism of action of PB.

01 Jul 2022·Biophysical Chemistry

Sulphonated azo dye decolorization by Alcaligenes faecalis subsp. phenolicus MB207: Insights from laboratory and computational analysis

Article

Author: Basharat, Zarrin ; Yasmin, Azra

Microbial decolorization of azo dyes, mediated by an enzymatic mechanism is an intricate cost-effective, and eco-friendly treatment method of genotoxic azo pollutants. Scientists are on the constant lookout for microbes, enzymes, and mechanisms that could aid remediation of the environment at a fast pace. Alcaligenes faecalis subsp. phenolicus MB207 is one such bacteria, consisting of azoreductase (AzoR) and laccase/multicopper oxidase enzyme responsible for sulphonated mono-azo dye (Methyl orange) and di-azo dye (Congo red) degradation. AzoR degrades dyes by a ping-pong setup while multicopper oxidase achieves this through a non-specified radical approach. We have coupled experimental analysis with bioinformatics for deciphering intricacies of this procedure in tiny scale enzymatic machines of this biotope. The degradation assays were followed by molecular docking of the enzyme-substrate complexes. Key anchoring bonds were detected and mapped H-bonding, electron exchange, ionic interactions, as well as hydrophobic interactions, provided insights into dye-enzyme and NADH-enzyme binding. This study establishes a foundation of the molecular basis of dye interaction with azoR and multicopper oxidase in A. facealis subsp. phenolicus MB207.

100 Deals associated with Amlodipine Besylate/Olmesartan Medoxomil

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine Besylate/Olmesartan Medoxomil	C09DB02	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	CN	Daiichi Sankyo Pharmaceutical (Shanghai) Co. Ltd.	12 Jul 2018
Hypertension	US	Cosette Pharmaceuticals, Inc.Startup	26 Sep 2007

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