A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers
Status:
Recruiting
Trial end date:
2021-11-20
Target enrollment:
Participant gender:
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.