The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ,then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment HR20031 FDC 10/100/1000 mg.
Subjects will receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout ,then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.
Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2 followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR\*2.
Jinan Central Hospital
Jinan, Shandong, China
Pharmacokinetics parameters of SHR3824 in the fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086 in the fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of Metformin in the fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SHR3824 in the fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086 in the fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of Metformin in the fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SHR3824 in the 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 and Day 15
Pharmacokinetics parameters of SP2086 in the 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 and Day 15
Pharmacokinetics parameters of Metformin in the 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 and Day 15
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Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ,then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment HR20031 FDC 5/50/750 mg\*2.
Subjects will receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout ,then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.
Subjects will receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3 followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg\*2 followed by 7 days washout and then receive treatment SHR3824 5 mg\*2+ SP2086 50 mg\*2+ Metformin 500 mg XR\*3.
Pharmacokinetics parameters of SP2086A in the fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086A in the fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086A in the 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 and Day 15
Pharmacokinetics parameters of SHR3824 in the fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of Metformin in the fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SHR3824 in the fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of Metformin in the fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SHR3824 in the fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Pharmacokinetics parameters of Metformin in the fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
The incidence and severity of adverse events/serious adverse events
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15