[Translation] A randomized, open-label, single-dose, two-drug, self-crossover controlled study to evaluate the bioequivalence of tulobuterol patch in Chinese healthy subjects in the fasting state

主要目的：以海南盈达润泽药业有限公司提供的妥洛特罗贴剂为受试制剂，按生物等效性试验的有关规定，与ヴィアトリス製薬株式会社持证的妥洛特罗贴剂（商品名：Hokunalin®，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。

[Translation]

Main purpose: Taking the tuloterol patch provided by Hainan Yingda Runze Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, it will be compared with the certified tuloterol patch produced by Biotech Co., Ltd. (Trade name: Hokunalin®, reference preparation) Compare the absorption speed and degree of absorption in healthy humans to examine the human bioequivalence of the two preparations.

Start Date01 Nov 2024

Sponsor / Collaborator

Hainan Yingda Runze Pharmaceutical Co., Ltd.

CTR20241848

/ CompletedNot Applicable

妥洛特罗贴剂在健康受试者空腹状态下的随机、开放、单剂量、两制剂、两序列、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, crossover bioequivalence study of tulobuterol patch in healthy subjects under fasting condition

主要目的：比较空腹单次给药条件下，北京泰德制药股份有限公司提供的妥洛特罗贴剂（规格：0.5mg/贴，受试制剂）与日东电工株式会社持证生产的妥洛特罗贴剂（商品名：阿米迪®，规格：0.5mg/贴，参比制剂）在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数，评价两者是否生物等效，为受试制剂的注册申请提供依据。次要目的：考察受试制剂和参比制剂在健康成人受试者体内的安全性、皮肤粘贴牢固度和皮肤刺激性。

[Translation]

Primary objective: To compare the differences in absorption degree and speed of the tulobuterol patch (specification: 0.5 mg/patch, test preparation) provided by Beijing Taide Pharmaceutical Co., Ltd. and the tulobuterol patch (trade name: Amidil®, specification: 0.5 mg/patch, reference preparation) produced by Nitto Denko Corporation under the condition of single fasting administration in healthy subjects. The main pharmacokinetic parameters were used to evaluate whether the two were bioequivalent, and to provide a basis for the registration application of the test preparation. Secondary objective: To investigate the safety, skin adhesion firmness and skin irritation of the test preparation and the reference preparation in healthy adult subjects.

Start Date15 Jun 2024

Sponsor / Collaborator

Beijing Tide Pharmaceutical Co., Ltd.

CTR20242657

/ CompletedNot Applicable

妥洛特罗贴剂在健康受试者中随机、开放、单剂量、两制剂、两周期、两序列交叉空腹状态下生物等效性预试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence pilot study of tulobuterol patch in healthy subjects under fasting conditions

主要目的：按照生物等效性试验的相关规定，以浙江海阁堂医药有限公司研制的妥洛特罗贴剂（1 mg/贴）为受试制剂，以日东电工株式会社生产的妥洛特罗贴剂（商品名：阿米迪®，1 mg/贴）为参比制剂，各服用1mg后根据妥洛特罗的体内经时过程，估算其药代动力学参数，初步评估两制剂是否具有生物等效性，为正式试验的方案设计提供修订依据；初步了解药物的药代动力学特性，为正式试验采血点设置提供依据；同时了解药物的浓度范围，为正式试验检测方法学的优化提供参考依据。次要目的：评价妥洛特罗贴剂在健康受试者体内的安全性、皮肤粘附性和皮肤刺激性。

[Translation]

Main purpose: According to the relevant provisions of the bioequivalence test, the tulobuterol patch (1 mg/patch) developed by Zhejiang Haigetang Pharmaceutical Co., Ltd. was used as the test preparation, and the tulobuterol patch (trade name: Amidie®, 1 mg/patch) produced by Nitto Denko Corporation was used as the reference preparation. After taking 1 mg of each, the pharmacokinetic parameters were estimated according to the in vivo time course of tulobuterol, and the two preparations were preliminarily evaluated to see whether they were bioequivalent, providing a basis for revising the design of the formal test plan; the pharmacokinetic properties of the drug were preliminarily understood, providing a basis for setting up the blood collection points for the formal test; and the concentration range of the drug was understood, providing a reference for optimizing the detection methodology of the formal test. Secondary purpose: To evaluate the safety, skin adhesion and skin irritation of the tulobuterol patch in healthy subjects.

Start Date06 Jun 2024

Sponsor / Collaborator

Zhejiang Haigetang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tulobuterol

100 Translational Medicine associated with Tulobuterol

100 Patents (Medical) associated with Tulobuterol

581

Literatures (Medical) associated with Tulobuterol

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.

01 Jan 2025·Microchemical Journal

Multi-residue analysis of pesticides and veterinary drugs by ultra-performance liquid chromatography-tandem mass spectrometry using a modified QuEChERS method

Author: Hou, Fan ; He, Yining ; Dai, Hancong ; Zhu, Yingchun ; Wang, Mengru ; Zhu, Xueting ; Wu, Lina ; Yang, Yao ; Huang, Mengyang

In food safety testing, simultaneous detection of multiple harmful residues is crucial because pesticide and veterinary drug residues often occur together.A method was developed for the simultaneous determination of residues of 20 pesticide and veterinary drug compounds in both buffalo and cow milk, utilizing a modified QuEChERS method combined with ultra-performance liquid chromatog.-tandem mass spectrometry (UPLC-MS/MS).The targeted analytes were efficiently extracted from milk matrixes using a 10 % formic acid solution in acetonitrile.Optimization of both pre-treatment and anal. parameters significantly enhanced the method′s sensitivity.Quantification was performed using matrix-matched calibration curves, which demonstrated exceptional linearity (R2 > 0.9990) across all analytes.Method validation, conducted with fortified blank milk samples at concentrations of 5, 10, and 50 μg/L, yielded recoveries ranging from 73.1 % to 111.6 %.The relative standard deviations for all analytes were consistently below 15 %, confirming the method′s precision.The limits of detection (LOD) and quantification (LOQ) were determined to be between 0.7 and 1.7 μg/L and 2.0 and 5.0 μg/L, resp.This method is straightforward, sensitive, accurate, and environmentally friendly, making it well-suited for the detection of multiple pesticides and antibiotics in milk.

01 Dec 2024·International Journal of Pharmaceutics

The molecular design of novel phospholipid-inspired ionic liquid transdermal penetration enhancers: Innovative insights on the action mode and mechanism

Article

Author: Yang, Degong ; Liu, Xinyu ; Chen, Xuejun ; Liu, Lin ; Hong, Bingrong ; Li, Ziqing ; Liu, Yang ; Yang, Chunrong

Ionic liquid transdermal penetration enhancers (IL@TPEs) as new enhancement methods have significant advantages in the transdermal drug delivery system. However, the scientific frameworks for the design of efficient IL@TPEs and their applications in transdermal formulations were still lack. So, a series of novel biomimetic phospholipid-inspired IL@TPEs (PIL@TPEs) were designed and synthesized. The developed QSARs proved that enhancement efficacy of PIL@TPEs depended on pKa of drugs and M.W., Polar., and pKa of cations. Surprisingly, the PIL@TPEs dissociated during transdermal process, and skin penetration amounts of acidic drugs was inversely proportional to skin retention amounts of cations, which showed that action modes of PIL@TPEs were different from conventional enhancers. The novel mechanisms of PIL@TPEs were elucidated by quantitative determination of dynamic interaction among cations, anions, drugs, and skins. The PIL@TPEs with high enhancement efficiency owned strong interactions with drugs determined by ATR-FTIR, Raman and NOESY. Moreover, the PIL@TPEs owning better stability in skin ensured the production of strong interactions with lipids and keratins characterized by ATR-FTIR, ¹H NMR and CLSM. The good safety of optimized PIL@TPEs was proved by determining cytotoxicity, apoptosis, inflammatory cells, and cytokines. In conclusion, this project will make an important contribution to the design and application of IL@TPEs.

100 Deals associated with Tulobuterol

External Link

KEGG	Wiki	ATC	Drug Bank
D02151	Tulobuterol	R03CC11 R03AC11	DB12248

R&D Status

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Indication	Country/Location	Organization	Date
Acute Bronchitis	South Korea	Abbott Laboratories	01 Sep 2004
Asthma	South Korea	Abbott Laboratories	01 Sep 2004
Bronchitis, Chronic	South Korea	Abbott Laboratories	01 Sep 2004
Pulmonary Emphysema	South Korea	Abbott Laboratories	01 Sep 2004
Respiratory Distress Syndrome, Adult	South Korea	Abbott Laboratories	01 Sep 2004

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