NCT05682495

A HR20031 BE Study on Healthy Subjects

A Bioequivalence Study of HR20031 Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	ARM A	Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment HR20031 FDC 10/100/1000 mg.
DRUG	ARM B	Subjects will receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.
DRUG	ARM C	Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.
DRUG	ARM D	Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ，then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment HR20031 FDC 5/50/750 mg\*2.
DRUG	ARM E	Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout ，then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.
DRUG	ARM F	Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.

Timeline

• Start date: 2023-01-31
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2023-01-12
• Last updated: 2023-04-07

Locations

1 site across 1 country: China