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A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers

Type II Diabetes Clinical Trial

Official title:
A Single-centre, Parallel-cohort, Open-label Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of the HR20033in Healthy Chinese Subjects

Clinical Trial Summary

According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group. The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the HR20033 FDC tablet in healthy Chinese subjects; (2) to characterize the single-dose and steady-state PK of SHR3824 and metformin following administration of the HR20033 FDC tablet to healthy subjects in the fed state. The secondary objective is to assess in healthy Chinese subjects, the safety and tolerability of the SHR3824 and Metformin after single doses (administered in the fed and fasted states) and multiple doses (administered in the fed state) of the HR20033 FDC tablet.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05120219
Study type Interventional
Source Shandong Suncadia Medicine Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 13, 2021
Completion date December 20, 2021
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