[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of arotinolol hydrochloride tablets in healthy Chinese adult subjects under fasting and fed conditions

主要目的：以长春海悦药业股份有限公司生产的盐酸阿罗洛尔片（规格：10 mg）为受试制剂，Sumitomo Pharma Co., Ltd.持证的盐酸阿罗洛尔片（商品名：阿尔马尔，规格：10 mg）为参比制剂，通过随机、开放、单次给药、两制剂、两序列、两周期、双交叉空腹和餐后临床试验来评价两种制剂在中国健康成年受试者体内的生物等效性。次要目的：评价中国健康成年受试者单次空腹和餐后口服盐酸阿罗洛尔片受试制剂T和参比制剂R后的安全性。

[Translation]

Primary objective: Using arotinolol hydrochloride tablets (specification: 10 mg) produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation and arotinolol hydrochloride tablets (trade name: Almar, specification: 10 mg) certified by Sumitomo Pharma Co., Ltd. as the reference preparation, the bioequivalence of the two preparations in healthy Chinese adult subjects was evaluated through a randomized, open, single-dose, two-preparation, two-sequence, two-cycle, double-crossover fasting and postprandial clinical trial. Secondary objective: To evaluate the safety of arotinolol hydrochloride tablets test preparation T and reference preparation R after a single fasting and postprandial oral administration in healthy Chinese adult subjects.

Start Date17 Feb 2025

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20244971

/ CompletedNot Applicable

盐酸阿罗洛尔片在健康受试者中随机、开放、单剂量、两周期、两序列、交叉设计的空腹和餐后状态下生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover-design bioequivalence study of arotinolol hydrochloride tablets in healthy subjects under fasting and fed conditions

主要研究目的研究空腹和餐后状态下单次口服盐酸阿罗洛尔片受试制剂（规格：10 mg，湖南尚众合生物医药有限公司）与盐酸阿罗洛尔片参比制剂（Almarl®（阿尔马尔），规格：10 mg，Sumitomo Pharma Co.,Ltd.）在中国健康成年受试者体内的药代动力学，评价空腹和餐后单次口服两种制剂的生物等效性。次要研究目的评价中国健康受试者空腹和餐后单次口服受试制剂（T）盐酸阿罗洛尔片和参比制剂（R）盐酸阿罗洛尔片（商品名：Almarl®（阿尔马尔））后的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test formulation of arotinolol hydrochloride tablets (specification: 10 mg, Hunan Shangzhonghe Biopharmaceutical Co., Ltd.) and the reference formulation of arotinolol hydrochloride tablets (Almarl®, specification: 10 mg, Sumitomo Pharma Co., Ltd.) in healthy Chinese adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two formulations after a single oral administration in the fasting and fed state. Secondary study objectives To evaluate the safety of the test formulation (T) arotinolol hydrochloride tablets and the reference formulation (R) arotinol hydrochloride tablets (trade name: Almarl®) after a single oral administration in healthy Chinese subjects after a fasting and fed state.

Start Date11 Feb 2025

Sponsor / Collaborator

Hunan Shangzhonghe Biopharmaceutical Co., Ltd.

NCT06780865

/ Not yet recruitingNot ApplicableIIT

Protection of Renal Function by Antihypertensive Treatment in Patients with Chronic Kidney Disease and Isolated Nighttime Hypertension

Hypertension guidelines recommend the application of ambulatory blood pressure monitoring in the diagnosis and treatment of patients with hypertension. Subtypes of hypertension such as nocturnal hypertension can be found through ambulatory blood pressure monitoring. Previous studies have reported that the prevalence of nocturnal hypertension, even isolated nocturnal hypertension, is higher in patients with chronic kidney disease, and it is associated with adverse events such as cardiovascular events and progression of renal dysfunction. However, the benefit of controlling nocturnal hypertension in patients with chronic kidney disease is unclear. In this study, a total of 200 patients with chronic kidney disease and isolated nocturnal hypertension will be enrolled. Patients will be randomly divided into two treatment groups: the active antihypertensive treatment group and the placebo treatment group (1:1). The antihypertensive treatment group will be treated with arotinolol or amlodipine and clonidine to control nocturnal blood pressure, while the control group will be treated with the corresponding placebos. Randomized patients will be followed up for 2 years to evaluate the effect of controlling isolated nocturnal hypertension on the progression of chronic kidney disease in terms of EPI-estimated glomerular filtration rate (eGFR) decline and change in proteinuria.

Start Date30 Jan 2025

Sponsor / Collaborator-

100 Clinical Results associated with Arotinolol Hydrochloride

100 Translational Medicine associated with Arotinolol Hydrochloride

100 Patents (Medical) associated with Arotinolol Hydrochloride

234

Literatures (Medical) associated with Arotinolol Hydrochloride

01 Jan 2025·BMJ Case Reports

Cholestasis due to biliary obstruction can cause cardiogenic shock with bradycardia by delaying the elimination of arotinolol

Article

Author: Yasu, Takeo ; Iizuka, Yuki ; Makino, Jun ; Urayama, Yasunori

Cardiogenic shock with bradycardia due to beta-blockers is well-documented; however, this condition in association with arotinolol is unreported. We present a case of cardiogenic shock resulting from delayed arotinolol clearance caused by bile duct obstruction. A man in his 60s presented to our hospital with jaundice. We suspected acute obstructive suppurative cholangitis; however, the patient did not exhibit fever or abdominal symptoms. Based on the physical examination results, we concluded the patient was in cardiogenic shock as a consequence of delayed arotinolol elimination. We attempted to maintain organ perfusion using norepinephrine and dopamine, with minimal response. On initiating isoproterenol, the heart rate stabilised. After tapering off isoproterenol, endoscopic retrograde cholangiopancreatography (ERCP) was performed. Subsequent serum arotinolol level measurement revealed a significant reduction in the elimination half-life before and after ERCP. In cases of cardiogenic shock associated with arotinolol, presumably eliminated via the bile duct, it is crucial to consider potential delayed elimination and to appropriately time ERCP.

01 Feb 2024·Chirality

Preparation of a bis‐triazolyl bridged β‐cyclodextrin stationary phase and its application for enantioseparation of chiral compounds by HPLC

Article

Author: Li, Laisheng ; Zeng, Qingli ; Li, Dan ; Huang, Zhiqin

AbstractA novel bis‐triazolyl bridged β‐cyclodextrin was first synthesized by the Click reaction between azido‐β‐cyclodextrin and 1,6‐heptadiyne. Then it was bonded onto silica gel to obtain a bis‐triazolyl bridged β‐cyclodextrin‐based chiral stationary phase (BCDP). After structure characterization, the HPLC performance of BCDP was systematically evaluated by using different types of compounds as probes. The results showed that BCDP could well separate 18 kinds of achiral aromatic compounds (homologues, positional isomers, etc.) and 35 kinds of chiral drugs or pesticides, such as triazoles (Rs = 1.33–3.15), flavanones (Rs = 1.49–2.62), dansyl amino acids (Rs = 0.96–1.99), and β‐blocker drugs (Rs = 0.68–2.78). BCDP could separate a wider range of compounds (53 kinds); especially, some chiral substance pairs that were difficult to be resolved on the ordinary cyclodextrin CSPs, including triazoles containing two chiral carbons (triadimenol, bitertanol, metconazole, and triticonazole), strongly ionized amino acids (acidic Asp, alkalic Arg, and polar Thr) and β‐blockers with bulky groups (carvedilol, propranolol, and pindolol). Obviously, the unique synergistic inclusion effect of bridged cyclodextrin with double cavities and the bis‐triazole bridging group could provide multiple action sites, such as hydrogen bonding, π‐π stacking and acid–base action sites, thus improving its chiral chromatographic performance.

04 Dec 2023·Die Pharmazie

Effect of baseline urinary glucose levels on the relationship between sodium-glucose cotransporter 2 inhibitors and serum uric acid in Japanese patients with type 2 diabetes mellitus.

Article

Author: Nakagawa, C ; Yokoyama, S ; Hosomi, K ; Uno, T ; Ota, R ; Hirata, A ; Tanaka, Y

In patients with type 2 diabetes mellitus (T2DM), controlling serum uric acid (SUA) and blood glucose levels is important. Moreover, sodium-glucose cotransporter 2 (SGLT2) inhibitors decrease SUA levels by accelerating urinary uric acid excretion. We investigated the effect of baseline urinary glucose levels on the relationship between SGLT2 inhibitors and SUA levels. We conducted a retrospective observational study using the electronic medical records of patients with T2DM of Kindai University Nara Hospital (April 2013 to March 2022). We divided the patients into two groups according to their baseline urinary glucose levels: the N-UG group, which included patients with negative urinary glucose strip test results (-), and the P-UG group, which included patients with positive urinary glucose strip test results (± or more). The changes in SUA levels before and after SGLT2 inhibitor administration were investigated. For comparison, the changes in SUA levels before and after the prescription of antidiabetic agents, excluding SGLT2 inhibitors, were also investigated. Our results revealed that SGLT2 inhibitors significantly decreased the SUA levels in patients in the N-UG group but tended to decrease its levels in those in the P-UG group. Regardless of the urinary glucose status at baseline, the administration of SGLT2 inhibitors may be useful for patients with T2DM to prevent the complications of hyperuricemia.

100 Deals associated with Arotinolol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01830	Arotinolol Hydrochloride	C07AB	DB09204

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Angina Pectoris	China	Sumitomo Pharma Co., Ltd.	03 Apr 1999
Arrhythmias, Cardiac	China	Sumitomo Pharma Co., Ltd.	03 Apr 1999
Hypertension	China	Sumitomo Pharma Co., Ltd.	03 Apr 1999

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