[Translation] A single-center, randomized, open-label, single-dose, two-period, two-crossover study to evaluate the bioavailability of Jungliflozin capsules and Jungliflozin pyroglutamate capsules in healthy subjects under fasting conditions

通过健康受试者在空腹状态下分别单次口服广东东阳光药业有限公司的荣格列净胶囊（50 mg，试验药物）与广东东阳光药业有限公司的焦谷氨酸荣格列净胶囊（50 mg，参比药物）进行人体相对生物利用度研究，比较试验药物与参比药物的药代动力学特征。

[Translation]

A relative bioavailability study was conducted in humans by taking a single oral dose of Rongpagliflozin Capsules (50 mg, test drug) produced by Guangdong East Sunshine Pharmaceutical Co., Ltd. and Rongpagliflozin Pyroglutamate Capsules (50 mg, reference drug) produced by Guangdong East Sunshine Pharmaceutical Co., Ltd. in the fasting state to compare the pharmacokinetic characteristics of the test drug and the reference drug.

Start Date13 Jul 2023

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

CTR20220023 / CompletedPhase 1

焦谷氨酸荣格列净胶囊在肾功能正常及轻、中度肾功能损害的中国2型糖尿病受试者中的药代动力学/药效学和安全性的I期研究

[Translation] Phase I study of the pharmacokinetics/pharmacodynamics and safety of pyroglutamic acid rongaliplatin capsules in Chinese type 2 diabetic subjects with normal renal function and mild to moderate renal impairment

评价焦谷氨酸荣格列净胶囊在肾功能正常及轻、中度肾功能损害的2型糖尿病受试者中的药代动力学特征，为焦谷氨酸荣格列净胶囊在肾功能损害患者中的临床应用提供理论依据。

[Translation]

To evaluate the pharmacokinetic characteristics of Rongagliflozin Pyroglutamate Capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment, and to provide a theoretical basis for the clinical application of Rongagliflozin Pyroglutamate Capsules in patients with renal impairment.

Start Date05 May 2022

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

NCT05374343 / Unknown statusPhase 1

A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment

To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.

Start Date05 May 2022

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

100 Clinical Results associated with Rongliflozin L-Pyroglutamic Acid

100 Translational Medicine associated with Rongliflozin L-Pyroglutamic Acid

100 Patents (Medical) associated with Rongliflozin L-Pyroglutamic Acid

Literatures (Medical) associated with Rongliflozin L-Pyroglutamic Acid

01 Feb 2020·Diabetes, Obesity and MetabolismQ2 · MEDICINE

Pharmacokinetics and pharmacodynamics of rongliflozin, a novel selective inhibitor of sodium‐glucose co‐transporter‐2, in people with type 2 diabetes mellitus

Q2 · MEDICINE

Article

Author: Zhang, Hong ; Li, Xiaojiao ; Li, Cuiyun ; Zhang, Yingjun ; Wu, Min ; Liu, Jingrui ; Liu, Chengjiao ; Ding, Yanhua ; Chen, Hong ; Zhu, Xiaoxue

AimsTo evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of rongliflozin in a cohort of healthy Chinese people and people with type 2 diabetes mellitus (T2DM).Materials and methodsWe examined the effects of a single ascending dose (SAD) of rongliflozin (10‐200 mg) in combination with food (20 mg) in 50 healthy people, and a multiple ascending dose (MAD) of rongliflozin (10‐50 mg once daily for 12 days) in 36 people with T2DM.ResultsNo serious adverse events (AEs) or discontinuations as a result of AEs (related to rongliflozin) occurred in either study. In healthy participants and those with T2DM, rongliflozin was rapidly absorbed, with a time to maximum plasma concentration of 0.63 to 1.75 hours. Systemic exposure (maximum observed serum concentration and area under the curve) to rongliflozin and its inactive major metabolites (T1444, T1454 and T1830) increased in proportion to dose. In the SAD and MAD studies, there was a dose‐related increase in urinary glucose excretion (UGE) ranging from 10 to 50 mg rongliflozin. This increase in UGE was associated with dose‐related decreases in serum glucose values in people with T2DM in the MAD group. In the SAD group, UGE plateaued at 50 to 200 mg.ConclusionsRongliflozin was well tolerated in all participants. The PK and PD measurements obtained for rongliflozin demonstrate a dose‐response relationship when the drug is administered at doses ranging from 10 to 50 mg in healthy people and in people with T2DM.

Chemical ScienceQ1 · CHEMISTRY

Atroposelective synthesis of N-aryl peptoid atropisomers via a palladium(ii)-catalyzed asymmetric C–H alkynylation strategy

Q1 · CHEMISTRY

ArticleOA

Author: Wu, Yong-Jie ; Yao, Qi-Jun ; Shi, Bing-Feng ; Zhou, Gang ; Xie, Pei-Pei ; Hong, Xin

The introduction of chirality into peptoids is an important strategy to determine a discrete and robust secondary structure.

100 Deals associated with Rongliflozin L-Pyroglutamic Acid

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	YiChang HEC ChangJiang Pharmaceutical Co., Ltd.	11 Jan 2024
Liver Injury	Phase 1	CN	Sunshine Lake Pharma Co., Ltd.	19 Apr 2022
Diabetes Mellitus	Phase 1	CN	Dongguan Dongyangguang Pharmaceutical R&D Co. Ltd.	30 Jan 2022
Diabetes Mellitus, Noninsulin-Dependent, 2	Preclinical	CN	Sunshine Lake Pharma Co., Ltd.	05 May 2022

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