NCT05120219

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
DRUG	FDC tablet	single HR20033 FDC tablet fed, take orally on an empty stomach and then after meals
DRUG	FDC tablet	single HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach
DRUG	FDC tablet	single and multiple doses of HR20033 FDC tablet

Timeline

• Start date: 2021-10-13
• Primary completion: 2021-11-17
• Completion: 2021-12-20
• First posted: 2021-11-15
• Last updated: 2021-11-24

Locations

1 site across 1 country: China