Study S001932

A Single Center, Open-label, Two Cohorts, Fixed Sequence Trial, Investigating the Influence of HRS9531 Injection on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration: NCT06723691
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 57
Start: 2024-12-18
Primary completion: 2025-06-09
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:Acetaminophen; DRUG:Metformin; DRUG:Warfarin; DRUG:Atorvastatin; DRUG:Digoxin; DRUG:HRS9531
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

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.]

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