[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study of Procaterol Hydrochloride Granules in healthy subjects under fasting and fed conditions

主要目的比较空腹和餐后给药条件下，黑龙江龙德药业有限公司提供的盐酸丙卡特罗颗粒（1g:50μg）与大塚製薬株式会社持证的盐酸丙卡特罗干糖浆（商品名：Meptin®，规格：0.005%）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的评价空腹和餐后给药条件下，黑龙江龙德药业有限公司提供的盐酸丙卡特罗颗粒（1g:50μg）与大塚製薬株式会社持证的盐酸丙卡特罗干糖浆（商品名：Meptin®，规格：0.005%）在健康成年人群中的安全性。

[Translation]

main purpose Comparing the conditions of fasting and postprandial administration, Procaterol Hydrochloride Granules (1g:50μg) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and Procaterol Hydrochloride Dry Syrup (Trade Name: Meptin®) certified by Otsuka Manufacturing Co., Ltd. , Specification: 0.005%) in healthy adults, the degree and rate of absorption are different, and its bioequivalence is evaluated. secondary purpose To evaluate the conditions of fasting and postprandial administration, Procaterol Hydrochloride Granules (1g:50μg) provided by Heilongjiang Longde Pharmaceutical Co., Ltd. and Procaterol Hydrochloride Dry Syrup (trade name: Meptin®) certified by Otsuka Manufacturing Co., Ltd. , specification: 0.005%) safety in healthy adults.

Start Date08 Nov 2024

Sponsor / Collaborator

Heilongjiang Longde Pharmaceutical Co., Ltd.

CTR20243542

/ CompletedNot Applicable

盐酸丙卡特罗干糖浆在中国健康人群中单次给药的人体生物等效性临床试验

[Translation] A human bioequivalence clinical trial of single-dose Procaterol hydrochloride dry syrup in healthy Chinese people

主要目的：以持证商为大塚製薬株式会社的盐酸丙卡特罗干糖浆（商品名：Meptin，规格：0.005%（g/g））为参比制剂，以重庆万霖生物医药科技有限公司研发的盐酸丙卡特罗干糖浆（规格：10g：0.5mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Use Procaterol Hydrochloride Dry Syrup (trade name: Meptin, Specification: 0.005% (g/g)) from Otsuka Seiki Co., Ltd. as the reference preparation, and Chongqing Wanlin Biomedical Technology Co., Ltd. The developed procaterol hydrochloride dry syrup (specification: 10g: 0.5mg) was the test preparation to evaluate the bioequivalence of the two preparations in Chinese healthy subjects under fasting and postprandial conditions. Secondary purpose: To observe the safety of the test preparation and reference preparation in Chinese healthy subjects.

Start Date14 Oct 2024

Sponsor / Collaborator

Chongqing Wanlin Biomedical Technology Co., Ltd.

CTR20242018

/ CompletedNot Applicable

随机、开放、单剂量、两制剂、自身交叉对照设计，评价中国健康受试者在空腹及餐后状态下单次口服盐酸丙卡特罗颗粒的生物等效性正式试验

[Translation] A randomized, open-label, single-dose, two-drug, self-crossover controlled study to evaluate the bioequivalence of a single oral dose of Procaterol Hydrochloride Granules in Chinese healthy subjects in the fasting and fed state

主要目的：以浙江百代医药科技有限公司提供的盐酸丙卡特罗颗粒为受试制剂，按生物等效性试验的有关规定，与大塚制药株式会社持证的盐酸丙卡特罗颗粒（商品名：Meptin®，参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂盐酸丙卡特罗颗粒和参比制剂盐酸丙卡特罗颗粒（Meptin®）在健康受试者中的安全性。

[Translation]

Main purpose: Using the procaterol hydrochloride granules provided by Zhejiang EMI Pharmaceutical Technology Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence testing, it is compared with the certified procaterol hydrochloride granules from Otsuka Pharmaceutical Co., Ltd. (trade name: Meptin ®, reference preparation) was compared with the absorption speed and degree of absorption in healthy humans to examine the human bioequivalence of the two preparations. Secondary purpose: To observe the safety of the test preparation Procaterol Hydrochloride Granules and the reference preparation Procaterol Hydrochloride Granules (Meptin®) in healthy subjects.

Start Date03 Jul 2024

Sponsor / Collaborator

Zhejiang Bio-diamond Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Procaterol Hydrochloride Hydrate

100 Translational Medicine associated with Procaterol Hydrochloride Hydrate

100 Patents (Medical) associated with Procaterol Hydrochloride Hydrate

726

Literatures (Medical) associated with Procaterol Hydrochloride Hydrate

01 Feb 2025·Analytical and Bioanalytical Chemistry

LC-HRMS screening procedure for the detection of 11 different classes of prohibited substances in dried urine spots for doping control purposes

Article

Author: Tsivou, Maria ; Pizzolato, Francesca ; Honesová, Lenka ; Gmeiner, Günter ; Mazzarino, Monica ; Van Eenoo, Peter

Dried urine spots have recently been proposed as an alternative matrix in the anti-doping field. Drying urine may open the opportunity to limit microbial and thermal degradation of the prohibited substances during transportation to the anti-doping laboratories without the need for refrigeration or freezing. In this study, a multi-targeted initial testing procedure was developed for the determination of 237 prohibited drugs/metabolites from 11 different classes in dried urine spots. The comparability between two different microsampling techniques (i.e., Whatman^® FTA DMPK-C cards and Mitra^® tips) was evaluated. The developed method was then used to evaluate the stability of the target compounds in urine for 7 days under different environmental conditions to simulate the transportation of the urine samples from the collection sites to anti-doping laboratories. Sample preparation consists of (i) extraction of the analytes from the collection device using a mixture of acetonitrile/methanol (1/1) for 30 min at 40 °C, (ii) enzymatic hydrolysis, and (iii) sample concentration by solid-phase extraction. Analysis was performed using liquid chromatography coupled to high-resolution mass spectrometry. The entire workflow was validated in terms of specificity (analytes were distinguishable from the matrix interferences), sensitivity (only with the Mitra^® tips the limits of detection comply with the World Anti-Doping Agency's requirements for the majority of the target compounds), carry-over (no signals in the negative urine injected after the positive urine), matrix effect (16-28% for Mitra^® tips and 22-35% for DMPK-C cards), and extraction yield (Mitra^® tips: 51-88%; DMPK-C cards: 40-76%). As proof of concept, authentic urine samples were analyzed: results obtained in dried urine were compared with those of fluid urine, providing good agreement. Stability studies showed that the target compounds were stable for the whole duration of the study (7 days) at -20 and 4 °C in both fluid and dried urine. At 50 °C or at 20-25 °C, several thiazide-based compounds were completely degraded to their degradation product in the first 24 h or after 3-4 days in fluid urine, whereas in dried urine the compounds were detectable for the entire duration of the study.

13 Dec 2024·Journal of Liquid Chromatography & Related Technologies

New method for rapid detection and simultaneous determination of prohibited adrenergic drugs in sports using thin layer chromatography and image processing

Author: Szasz, Melinda Carmen ; Cobzac, Simona Codruța Aurora ; Büker, Eda ; Casoni, Dorina

This study presents a new method for simultaneous determination of fenoterol, procaterol, clenbuterol, terbutaline and isoprenaline drugs using thin-layer chromatog. assisted by image anal. (HPTLC-IA) combined with sensitive detection modes.Separation of the selected drugs was obtained using HPTLC Silica gel 60 F254 plates and mixture of iso-Pr alc., Et acetate and ammonia (20:25:1.5 volume/volume/v) as mobile phase.UV detection mode combined with the use of 2,2-diphenyl-1-picrylhydrazyl (DPPH.) and 2,2-azino-bis (3-ethylbenzothiazoline)-6-sulfonic acid (ABTS+bul) radicals were applied for the first time for sensible detection of the separated drugs.Gray, green, red and blue scales resp. were selected for image anal. and accurate quantification of spot area.According to the obtained result, the use of DPPH. and ABTS+bul reagents revealed a higher sensitivity in detection and accurate quantification of the analyzed drugs.Lower limit of detection (LOD = 0.07 ± 0.03μg/spot; 0.09 ± 0.03μg/spot and 0.10 ± 0.04μg/spot) was obtained for fenoterol, procaterol and terbutaline using the ABTS+bul radical and red scale selection for image processing.With the exception of isoprenaline, the proposed HPTLC-IA method showed a good separation of fenoterol, procaterol, clenbuterol and terbutaline drugs from other compounds in urine samples.Good recovery was obtained for these drugs in spiked urine samples.

01 Nov 2024·Journal of Chromatography A

Clindamycin phosphate-based deep eutectic solvent as a chiral selector for enantioseparation of amino alcohol drugs in nonaqueous capillary electrophoresis

Article

Author: Ma, Xiaofei ; Zhang, Chengchen

Clindamycin phosphate (CP) exhibits good enantioselectivity for many basic drugs, but its separation effect for most amino alcohol drugs is not satisfactory. In this work, a deep eutectic solvent (DES) chiral selector based on CP was prepared for the first time and utilized as a single chiral selector in nonaqueous capillary electrophoresis (NACE) to separate twelve amino alcohol drugs. Compared with unmodified CP, the separations of model drugs in the DES chiral selector system were significantly improved. Most amino alcohol drugs could be completely separated, and the peak shapes were good. In addition, we used infrared spectroscopy and nuclear magnetic resonance method to study the specific separation mechanism and explored the reasons why DES chiral selector has better enantioselectivity. This work is the first to directly modify antibiotic chiral selector into DES, indicating a direction for us to develop novel chiral recognition materials.

100 Deals associated with Procaterol Hydrochloride Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Procaterol Hydrochloride Hydrate	R03AC16 R03CC08	DB01366

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	China	Zhejiang Otsuka Pharmaceutical Co. Ltd.	01 Jan 1993
Asthma	Japan	Otsuka Pharmaceutical Co., Ltd.	25 Oct 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 2	Taiwan Province	Taiwan Otsuka Pharmaceutical Co., Ltd.	01 Mar 2009
Acute asthma	Phase 2	Indonesia	PT Otsuka Indonesia	01 Jun 2007

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2013	Not Applicable	Pulmonary Disease, Chronic Obstructive	-	SABA (20 Âµg of inhaled procaterol)	ubkrywnxvl(ctexfhgwoc) = duydcekbcp luxvbhanyw (lidprmjaui ) View more	Positive	01 Sep 2013
				Placebo	ubkrywnxvl(ctexfhgwoc) = prbtcimmty luxvbhanyw (lidprmjaui ) View more

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