[Translation] A single-center, randomized, open-label, two-dose, fasting, single-dose, two-period, double-crossover bioequivalence study of miglitol tablets developed by Beijing Beilu Pharmaceutical Co., Ltd. and the original reference preparation in healthy Chinese subjects

以北京北陆药业股份有限公司研制的米格列醇片为受试制剂，三和化学研究所株式会社持证的米格列醇片SEIBULE®为参比制剂，考察两制剂在空腹状态下单次给药的药效学差异和药动学差异，评价两制剂是否生物等效，同时评价两种制剂在健康人体中的安全性。

[Translation]

Miglitol tablets developed by Beijing Beilu Pharmaceutical Co., Ltd. were used as the test preparation, and SEIBULE® miglitol tablets certified by Sanwa Chemical Research Institute Co., Ltd. were used as the reference preparation. The pharmacodynamic and pharmacokinetic differences of the two preparations after a single dose in the fasting state were investigated, and whether the two preparations were bioequivalent was evaluated. At the same time, the safety of the two preparations in healthy humans was evaluated.

Start Date04 Apr 2025

Sponsor / Collaborator

Beijing Beilu Pharmaceutical Co., Ltd.

CTR20250552

/ CompletedNot Applicable

米格列醇片(50mg)在健康受试者中的单次给药、随机、开放、两制剂、两序列、两周期、双交叉、空腹状态下的PK和PD生物等效性研究

[Translation] A single-dose, randomized, open-label, two-formulation, two-sequence, two-period, double-crossover, fasting PK and PD bioequivalence study of miglitol tablets (50 mg) in healthy subjects

主要研究目的:以三和化学研究所株式会社持证的米格列醇片(商品名:Seibule)为参比制剂，以武汉维奥制药有限公司生产的米格列醇片为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉、空腹状态下的临床研究来评价两种制剂在空腹条件下的PK和PD 人体生物等效性。次要研究目的: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]

The main purpose of the study is to use Miglitol Tablets (trade name: Seibule) certified by Sanwa Chemical Research Institute Co., Ltd. as the reference preparation and Miglitol Tablets produced by Wuhan Via Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the PK and PD human bioequivalence of the two preparations under fasting conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-cycle, double-crossover, fasting clinical study. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date25 Feb 2025

Sponsor / Collaborator

Wuhan Wei'Ao Pharmaceutical Co Ltd

CTR20244108

/ CompletedNot Applicable

米格列醇片在健康受试者中的单剂量、空腹、随机、开放、两周期、两交叉生物等效性研究

[Translation] A single-dose, fasting, randomized, open-label, two-period, two-crossover bioequivalence study of miglitol tablets in healthy subjects

主要研究目的：本研究以成都倍特药业股份有限公司生产的米格列醇片为受试制剂，日本株式会社三和化学研究所生产的米格列醇片（商品名：SEIBULE®）为参比制剂，评价受试制剂和参比制剂在空腹条件下口服给药时的药效动力学和药代动力学生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main research purpose: This study uses Miglitol Tablets produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation and Miglitol Tablets (trade name: SEIBULE®) produced by Sanwa Chemical Research Institute Co., Ltd. of Japan as the reference preparation to evaluate the pharmacodynamics and pharmacokinetic bioequivalence of the test preparation and the reference preparation when administered orally under fasting conditions. Secondary research purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date02 Dec 2024

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

100 Clinical Results associated with Miglitol

100 Translational Medicine associated with Miglitol

100 Patents (Medical) associated with Miglitol

777

Literatures (Medical) associated with Miglitol

01 May 2025·Journal of Molecular Graphics and Modelling

Molecular interaction profiling and binding dynamics of Cinnamomum zeylanicum phytochemicals with human pancreatic amylase

Article

Author: Shanti, Koppala Narayanappa ; Rao, Vyshnavi Vishwanadham

Diabetes mellitus, characterized by persistent hyperglycemia, remains a critical global health challenge. Inhibition of human pancreatic alpha-amylase, a key enzyme catalyzing carbohydrate digestion, is a promising approach to manage postprandial glucose levels. Cinnamomum zeylanicum, a medicinal plant known for its therapeutic potential, harbors bioactive compounds that can act as natural alpha-amylase inhibitors, though their mechanisms remain underexplored. In this study, molecular docking and 200 ns molecular dynamics (MD) simulations were employed to evaluate the inhibitory potential of 18 phytochemicals derived from Cinnamomum zeylanicum. Two lead compounds, 1HE (1,2,4a,5,6,8a-Hexahydro-1-isopropyl-4,7-dimethylnaphthalene) and C4B (cis-4-Benzyl-2,6-diphenyl-tetrahydropyran), exhibited superior binding affinities (-7.91 and -8.78 kcal/mol, respectively) compared to the FDA-approved inhibitors, acarbose (-8.2 kcal/mol) and miglitol (-5.6 kcal/mol). MD simulations confirmed the stability of the complexes, with RMSD values of 0.21 ± 0.02 nm for 1HE and 0.24 ± 0.03 nm for C4B, showing minimal structural deviations. Structural analyses, including radius of gyration (Rg) and solvent-accessible surface area (SASA), revealed stable and compact protein-ligand conformations. Notably, free energy landscape (FEL) analysis indicated that C4B induces multiple metastable states, suggesting a dynamic inhibitory mechanism potentially involving allosteric regulation. These results highlight 1HE and C4B as promising natural inhibitors with favorable stability, binding characteristics, and inhibitory mechanisms. Further in vitro and in vivo studies are warranted to validate their therapeutic potential as safe and effective alternatives for diabetes management.

01 Mar 2025·Analytica Chimica Acta

Expanding the chemical coverage of polar compounds in water analysis by coupling supercritical fluid with hydrophilic interaction chromatography high-resolution mass spectrometry

Article

Author: Emke, E ; Cerrato, A ; Amato, E D ; Gargano, A F G ; Holmark, T

BACKGROUNDPersistent and mobile organic compounds (PMOC) are of great concern for water quality and human health. The recent improvement and availability of high-resolution mass spectrometry in combination with liquid chromatography have widely expanded the potential of analytical workflows for their detection and quantitation in water. Given their high polarity, the detection of some PMOC requires alternative techniques to reversed-phase chromatography, such as hydrophilic interaction liquid chromatography (HILIC) and supercritical fluid chromatography (SFC). Unified chromatography (UC), an SFC gradient in which the state of the mobile phase changes continuously from supercritical to liquid at 100 % polar co-solvent, has shown potential for the analysis of compounds in a broad range of polarity, including very polar compounds.RESULTSIn the present study, for the first time, a UC-HILIC method coupled with high-resolution mass spectrometry was set up for PMOC analysis in water. SFC and HILIC gradients were run sequentially on the same bare-silica column, with the first separation running to 100 % modifier (UC) followed by a HILIC gradient transitioning to water. The UC and UC-HILIC gradients were previously optimized on a mix of 18 representative PMOC to assess solvent and mobile phase composition and for the instrumental system setup. The final method was employed for the analysis of water samples in comparison with a traditional reversed-phase separation, resulting in a significant increase in the number of annotated polar PMOC, including compounds listed in the Candidate List of substances of very high concern for Authorisation by the European Chemicals Agency.SIGNIFICANCEThe proposed approach represents a robust alternative to traditional methods for broadening the chemical space of separation and mass spectrometric detection. The introduction of the HILIC section of the gradient was necessary for the elution of strongly retained compounds on the silica phase, thus also reducing the amount of compounds that would be permanently bound onto the phase of the column, resulting in possible irreproducibility, pressure increase, and loss of efficiency in the compound separation.

01 Jan 2025·Journal of Chromatography B

Non-targeted screening of illegal added hypoglycemic drugs and their derivatives in functional foods using characteristic fragment ions scanning based on liquid chromatography-high-resolution mass spectrometry

Article

Author: Liu, Yajie ; Feng, Xuesong ; Wang, Xiujuan ; Du, Rongzhu ; Zhang, Feng ; Feng, Feng

Functional foods that are illegally adulterated with chemical hypoglycemic drugs or their derivatives pose serious risks to human health. However, the detection of these compounds is a challenge due to the unknown nature of their structures, particularly as many of these compounds are newly synthesized and lack standardized references. In this study, we developed a non-targeted screening strategy for detecting illegally added hypoglycemic drugs and their derivatives in oral solution and hard capsule functional foods. This strategy utilizes a self-established characteristic fragment ions mass spectrum database based on ultrahigh-performance liquid chromatography-quadrupole/orbitrap high-resolution mass spectrometry. Nine characteristic fragment ions were identified by analyzing the mass spectrometric fragmentation patterns of hypoglycemic drugs. Meanwhile, the precursor and fragment ions of 38 known hypoglycemic drugs were collected and incorporated into the mass database. The detection limits of hypoglycemic drugs in oral solution and hard capsule samples were 0.01-10 μg/L and 0.01-50 μg/kg, respectively. Applying the non-targeted method to 20 batches of suspicious samples, we found that 3 batches of samples contained illegal added drugs. Furthermore, we identified a previously unrecorded hypoglycemic drug not present in the mass database. These results indicate that the developed strategy is a powerful tool for the rapid and highly sensitive identification of both known and unknown hypoglycemic drugs, as well as their derivatives in functional foods.

100 Deals associated with Miglitol

External Link

KEGG	Wiki	ATC	Drug Bank
D00625	Miglitol	A10BF02	DB00491

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	Japan	Sanwa Kagaku Kenkyusho Co., Ltd.	11 Oct 2005
Diabetes Mellitus, Type 2	Netherlands	-	23 Jul 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Noninsulin-Dependent, 2	Phase 2	Japan	Sanwa Kagaku Kenkyusho Co., Ltd.	07 Jun 2006
Diabetes Mellitus, Type 1	Phase 2	Japan	Sanwa Kagaku Kenkyusho Co., Ltd.	21 Sep 2005
Obesity	Phase 1	United States	Pfizer Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2020	Not Applicable	-	-	Portal vein miglitol infusion upstream	qpbprxypdf(xzyuqsxohs) = lsdsswcalp jizajrebgo (ypueehbjyj ) View more	-	01 Jun 2020
				Portal vein miglitol infusion liver adjacent	qpbprxypdf(xzyuqsxohs) = fjzjtjuoef jizajrebgo (ypueehbjyj ) View more
JPRN-UMIN000006098 (EASD2013)	Not Applicable	Overweight	41	Miglitol	mjyachvlmf(cysseuafqn) = yelkpuyosw evyktpvgox (scqiolfffg, 0.11) View more	Positive	24 Sep 2013
				Sitagliptin	mjyachvlmf(cysseuafqn) = ytztomvixu evyktpvgox (scqiolfffg, 0.17) View more

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