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Clinical Trial Details

Trial ID: L2455
Source ID: NCT06723691
Associated Drug: Acetaminophen
Title: Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Acetaminophen|DRUG: Metformin|DRUG: Warfarin|DRUG: Atorvastatin|DRUG: Digoxin|DRUG: HRS9531
Outcome Measures: Primary: Area under the acetaminophen plasma concentration-time curve, From time 0 to 24 hours after a single dose.|Maximum observed acetaminophen concentration, From time 0 to 24 hours after a single dose.|Time of maximum observed acetaminophen concentration, From time 0 to 24 hours after a single dose.|Area under the metformin plasma concentration-time curve, From time 0 to 12 hours after the last of 7 repeated doses.|Area under the S-warfarin plasma concentration-time curve, From time 0 to 168 hours after a single dose.|Area under the atorvastatin plasma concentration-time curve, From time 0 to 72 hours after a single dose.|Area under the digoxin plasma concentration-time curve, From time 0 to 120 hours after a single dose. | Secondary: Area under the concentration versus time curve of acetaminophen from 0 to infinity, Start of treatment up to 168 hours.|Apparent volume of distribution of acetaminophen, Start of treatment up to 168 hours.|Time of maximum observed metformin concentration after 3.5 days of treatment, Start of Treatment up to 30 hours.|Clearance of metformin after 3.5 days of treatment, Start of Treatment up to 30 hours.|Apparent volume of distribution of metformin after 3.5 days of treatment, Start of Treatment up to 30 hours.|Time of maximum observed S-warfarin concentration, Start of Treatment up to 168 hours.|Clearance of S-warfarin, Start of Treatment up to 168 hours.|Apparent volume of distribution of S-warfarin, Start of Treatment up to 168 hours.|Time of maximum observed atorvastatin (and its active metabolites) concentration, Start of Treatment up to 72 hours.|Clearance of atorvastatin (and its active metabolites), Start of Treatment up to 72 hours.|Time of maximum observed digoxin concentration, Start of Treatment up to 120 hours.|Maximum observed digoxin concentration, Start of Treatment up to 120 hours.|Clearance of digoxin, Start of Treatment up to 120 hours.|Apparent volume of distribution of digoxin, Start of Treatment up to 120 hours.|Time of maximum observed HRS9532 concentration, Start of Treatment up to 168 hours.|Maximum observed HRS9531 concentration, Start of Treatment up to 168 hours.|Area under the concentration versus time curve of HRS9531 from 0 to the time of the last measurable (positive) concentration, Start of Treatment up to 168 hours.|Area under the concentration versus time curve of HRS9531 from 0 to infinity, Start of Treatment up to 168 hours.|Incidence and severity of adverse events, Screening period up to 117 days.
Sponsor/Collaborators: Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 57
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-18
Completion Date: 2025-05
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/NCT06723691