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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
single HR20033 FDC tablet fed, take orally on an empty stomach and then after meals
single HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach
single and multiple doses of HR20033 FDC tablet
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Cmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: AUC0-inf
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: Cmax,ss
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: AUCss
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.