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Clinical Trial Details

Trial ID: L4330
Source ID: NCT05120219
Associated Drug: Fdc Tablet
Title: A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type II Diabetes
Interventions: DRUG: FDC tablet|DRUG: FDC tablet|DRUG: FDC tablet
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, 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, 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, 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, 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, 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 | 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: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-10-13
Completion Date: 2021-12-20
Results First Posted:
Last Update Posted: 2021-11-24
Locations: The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230031, China
URL: https://clinicaltrials.gov/show/NCT05120219