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Clinical Trial Details

Trial ID: L3407
Source ID: NCT05692934
Associated Drug: Hr20031 Fdc
Title: A HR20031 FE Study on Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: HR20031 FDC|DRUG: HR20031 FDC|DRUG: HR20031 FDC|DRUG: HR20031 FDC
Outcome Measures: Primary: Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax, 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, 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, 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, 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, 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, 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), 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), 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), Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | Secondary: Pharmacokinetics parameters of SP2086A in the fast and fed state: Cmax, 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, 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), 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, From signed the informed consent form to Day 15 safety visit
Sponsor/Collaborators: Sponsor: Shandong Suncadia Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-31
Completion Date: 2023-03-11
Results First Posted:
Last Update Posted: 2023-04-04
Locations: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT05692934