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Clinical Trial Details

Trial ID: L5860
Source ID: NCT06654960
Associated Drug: Hrs9531 Injection
Title: Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: HRS9531 injection|DRUG: Metformin Hydrochloride tablets
Outcome Measures: Primary: Area under the concentration versus time curve (AUC) of metformin from dosing time (0) to tau (dosing interval) (AUCtau) after 3.5 days., Start of treatment up to 12 hours. | Secondary: Time to maximum concentration (Tmax) of metformin after 3.5 days of treatment., Start of Treatment up to 30 hours.|Maximum concentration (Cmax) of metformin after 3.5 days of treatment., Start of Treatment up to 30 hours.|Area under the concentration versus time curve of metformin from 0 to the time of the last measurable (positive) concentration (AUC0-t) after 3.5 days of treatment., Start of Treatment up to 30 hours.|Area under the concentration versus time curve of metformin from 0 to infinity (AUC0-inf) after 3.5 days of treatment., Start of Treatment up to 30 hours.|Terminal half-life (t1/2) of metformin after 3.5 days of treatment., Start of Treatment up to 30 hours.|Clearance (CL/F) of metformin after 3.5 days of treatment., Start of Treatment up to 30 hours.|Apparent volume of distribution (VzF) of metformin after 3.5 days of treatment., Start of Treatment up to 30 hours.|Time to maximum concentration (Tmax) of HRS9531., Start of Treatment up to 504 hours.|Maximum concentration (Cmax) of HRS9531., Start of Treatment up to 504 hours.|Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration (AUC0-t)., Start of Treatment up to 30 hours.|Area under the concentration versus time curve of HRS9531 from 0 to infinity (AUC0-inf)., Start of Treatment up to 504 hours.|Terminal half-life (t1/2) of HRS9531., Start of Treatment up to 504 hours.|Clearance (CL/F) of HRS9531., Start of Treatment up to 504 hours.|Apparent volume of distribution (VzF) of HRS9531., Start of Treatment up to 504 hours.|Incidence and severity of adverse events., Screening period up to 42 days.
Sponsor/Collaborators: Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-05
Completion Date: 2024-12-26
Results First Posted:
Last Update Posted: 2025-01-07
Locations: The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230000, China
URL: https://clinicaltrials.gov/show/NCT06654960