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Clinical Trial Details

Trial ID: L4021
Source ID: NCT05108350
Associated Drug: T1: Fdc 5/500 Mg; R1+R: Shr3824 5 Mg + Metformin 500 Mg Xr
Title: A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type II Diabetes
Interventions: DRUG: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR|DRUG: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR|DRUG: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR|DRUG: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
Outcome Measures: Primary: Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax, 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, 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 (if applicable), Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 | Secondary: Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax, 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, 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, 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, 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, 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, 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, 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, Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Sponsor/Collaborators: Sponsor: Shandong Suncadia Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-09
Completion Date: 2021-12-10
Results First Posted:
Last Update Posted: 2021-11-04
Locations:
URL: https://clinicaltrials.gov/show/NCT05108350