A Single-center, Single-arm, Open, Fixed-sequence, Self-controlled Study of the Pharmacokinetic Effects of HRS-1780, Henagliflozin, Metformin, and HRS-7535 in Healthy Subjects

This study was designed as a single-center, single-arm, open, fixed-sequence, self-controlled trial in healthy subjects.

Start Date01 Jul 2024

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

NCT05108350 / Unknown statusPhase 1

A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State

The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state.
The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.

Start Date09 Nov 2021

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

CTR20212413 / CompletedPhase 1

健康受试者高脂餐后状态下单次口服受试制剂HR20033片和参比制剂脯氨酸恒格列净片、盐酸二甲双胍缓释片的随机、开放、两周期、双交叉生物等效性研究

[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of a single oral dose of the test preparation HR20033 tablets and the reference preparations proline henggliflozin tablets and metformin hydrochloride extended-release tablets in healthy subjects after a high-fat meal

主要目的：评价高脂饮食对健康志愿者单次口服HR20033片后恒格列净和二甲双胍的药代动力学影响；评估健康志愿者餐后状态下多次口服HR20033片后恒格列净和二甲双胍的药代动力学特征。次要目的：评价空腹与高脂餐后状态下健康受试者单次口服HR20033片的安全性和耐受性；评价餐后状态下健康受试者多次口服HR20033片的安全性和耐受性。

[Translation]

Primary objective: To evaluate the effect of high-fat diet on the pharmacokinetics of henggliflozin and metformin after a single oral administration of HR20033 tablets in healthy volunteers; to evaluate the pharmacokinetic characteristics of henggliflozin and metformin after multiple oral administration of HR20033 tablets in healthy volunteers in the fed state. Secondary objective: To evaluate the safety and tolerability of a single oral administration of HR20033 tablets in healthy subjects in the fasting and high-fat meal states; to evaluate the safety and tolerability of multiple oral administration of HR20033 tablets in healthy subjects in the fed state.

Start Date03 Nov 2021

Sponsor / Collaborator

Shandong Suncadia Medicine Co., Ltd.Startup

100 Clinical Results associated with Henagliflozein Proline/Metformin Hydrochloride

100 Translational Medicine associated with Henagliflozein Proline/Metformin Hydrochloride

100 Patents (Medical) associated with Henagliflozein Proline/Metformin Hydrochloride

Literatures (Medical) associated with Henagliflozein Proline/Metformin Hydrochloride

01 Apr 2023·Clinical Pharmacology in Drug Development

Effects of Food and Multiple‐dose Administration on the Pharmacokinetic Properties of HR20033, a Sustained‐release Formulation of Henagliflozin and Metformin for the Treatment of Diabetes, in Healthy Chinese Volunteers

Article

Author: Zhang, Qian ; Liu, Yueyue ; Hu, Wei ; Li, Yijing ; Zhang, Qing ; Huyan, Xiaoyuan ; Qing, Huiling ; Wang, Xihan ; Liu, Zeyuan

AbstractHenagliflozin proline and metformin hydrochloride sustained‐release tablets (HR20033) are a fixed‐dose combination of the novel, highly selective, and effective sodium‐glucose cotransporter‐2 inhibitor henagliflozin, with a metformin sustained‐release layer for the treatment of type 2 diabetes mellitus in conjunction with dietary control and exercise. The aims of this study were to investigate the effect of a high‐fat diet on the pharmacokinetics of henagliflozin and metformin after a single administration of HR20033 and the effect of repeated oral administration of HR20033 on their pharmacokinetics in healthy volunteers. The food‐effect clinical study involved 18 healthy subjects randomized to receive either HR20033 in the fasted condition followed by HR20033 in the fed condition or the reverse schedule, with the two doses separated by a washout period of at least 7 days. The multiple‐dose clinical study was conducted on 10 healthy subjects. In the food‐effect study, compared with those in the fasted condition, the area under the blood concentration curve (AUC) and peak concentration (Cmax) of henagliflozin decreased by 12.64% and 40.89%, respectively, while the AUC of metformin increased by 31.13% and Cmax decreased by 7.09% in the fed state. There was no significant accumulation of HR20033 in the body after multiple oral doses. No serious adverse event was observed in either of the two clinical studies. Food did not have a clinically meaningful effect on the absorption of HR20033.

100 Deals associated with Henagliflozein Proline/Metformin Hydrochloride

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	CN	Shandong Suncadia Medicine Co., Ltd.Startup	29 Dec 2023

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Discovery	-	Shandong Suncadia Medicine Co., Ltd.Startup	09 Nov 2021

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