The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg in the fed state .
Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg in the fast state.
Subjects will receive treatment S HR20031 FDC 5/50/750 mg\*2 in the fast state followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 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.
Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 in the fed state followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg\*2 in the fast state.
Pharmacokinetics parameters of SP2086A in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Time frame: From signed the informed consent form to Day 15 safety visit