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Clinical Trial Details

Trial ID: L3613
Source ID: NCT05682495
Associated Drug: Arm A
Title: A HR20031 BE Study on Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: ARM A|DRUG: ARM B|DRUG: ARM C|DRUG: ARM D|DRUG: ARM E|DRUG: ARM F
Outcome Measures: Primary: Pharmacokinetics parameters of SHR3824 in the fed state: Cmax, 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, 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, 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, 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, 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, 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), 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), 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), Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | Secondary: Pharmacokinetics parameters of SP2086A in the fed state: Cmax, 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, 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), 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15
Sponsor/Collaborators: Sponsor: Shandong Suncadia Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-01-31
Completion Date: 2023-04-04
Results First Posted:
Last Update Posted: 2023-04-07
Locations: Jinan Central Hospital, Jinan, Shandong, 250013, China
URL: https://clinicaltrials.gov/show/NCT05682495