Delving into the Latest Updates on Prusogliptin/Metformin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

普卢格列汀二甲双胍

Target

DPP-4 x GPD1 x PRKAB1

Action

inhibitors, modulators, activators

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), GPD1 modulators(glycerol-3-phosphate dehydrogenase 1 modulators), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

CSPC Ouyi Pharmaceutical Co., Ltd.

Active Organization

CSPC Ouyi Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseClinical

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC16H25FN4O2

InChIKeyVQKSCYBKUIDZEI-STQMWFEESA-N

CAS Registry1186426-66-3

View All Structures (2)

主要目的：第一部分评价健康受试者餐后状态下单次口服普卢格列汀二甲双胍缓释固定剂量复方片剂与普卢格列汀片和盐酸二甲双胍缓释片联合给药的生物等效性；第二部分评价食物对健康受试者单次口服普卢格列汀二甲双胍缓释固定剂量复方片剂后的普卢格列汀和盐酸二甲双胍的药代动力学影响。次要目的：评价健康受试者单次口服受试制剂和参比制剂后的安全性。

[Translation]

Main objectives: The first part evaluates the bioequivalence of a single oral administration of plutagliptin metformin extended-release fixed-dose combination tablets and a combined administration of plutagliptin tablets and metformin hydrochloride extended-release tablets in healthy subjects in the fed state; the second part evaluates the effect of food on the pharmacokinetics of plutagliptin and metformin hydrochloride after a single oral administration of plutagliptin metformin extended-release fixed-dose combination tablets in healthy subjects. Secondary objectives: To evaluate the safety of the test preparation and the reference preparation after a single oral administration in healthy subjects.

Start Date21 Jul 2025

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

CTR20252050

/ RecruitingNot Applicable

普卢格列汀二甲双胍缓释片与对应剂量单独片剂联合给药在健康受试者中随机、开放、单次给药、两周期、交叉下的生物等效性以及食物对普卢格列汀二甲双胍缓释片在健康受试者中的药代动力学影响的研究

[Translation] A randomized, open-label, single-dose, two-period, crossover study of the bioequivalence of Plutagliptin and Metformin Extended-Release Tablets in healthy subjects and the effect of food on the pharmacokinetics of Plutagliptin and Metformin Extended-Release Tablets in healthy subjects

主要目的：第一部分评价健康受试者餐后状态下单次口服普卢格列汀二甲双胍缓释固定剂量复方片剂与普卢格列汀片和盐酸二甲双胍缓释片联合给药的生物等效性；第二部分评价食物对健康受试者单次口服普卢格列汀二甲双胍缓释固定剂量复方片剂后的普卢格列汀和盐酸二甲双胍的药代动力学影响。次要目的：评价健康受试者单次口服受试制剂和参比制剂后的安全性。

[Translation]

Main objectives: The first part evaluates the bioequivalence of a single oral administration of plutagliptin metformin extended-release fixed-dose combination tablets and a combined administration of plutagliptin tablets and metformin hydrochloride extended-release tablets in healthy subjects in the fed state; the second part evaluates the effect of food on the pharmacokinetics of plutagliptin and metformin hydrochloride after a single oral administration of plutagliptin metformin extended-release fixed-dose combination tablets in healthy subjects. Secondary objectives: To evaluate the safety of the test preparation and the reference preparation after a single oral administration in healthy subjects.

Start Date11 Jun 2025

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Prusogliptin/Metformin

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100 Translational Medicine associated with Prusogliptin/Metformin

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100 Patents (Medical) associated with Prusogliptin/Metformin

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100 Deals associated with Prusogliptin/Metformin

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