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Clinical Trial Details

Trial ID: L0494
Source ID: NCT06238388
Associated Drug: Hsk21542 Injection
Title: Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease Patients
Interventions: DRUG: HSK21542 Injection
Outcome Measures: Primary: Cumulative recovery of unchanged drug (Ae), The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate, From the start of administration to 168 hours after administration|Cumulative recovery fraction of unchanged drug (Fe), The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate, From the start of administration to 168 hours after administration|Plasma clearance, The pharmacokinetic parameters of HSK21542 in urine, feces, and dialysate, From the start of administration to 168 hours after administration|Cmax, The pharmacokinetic parameters of HSK21542 in plasma, From the start of administration to 168 hours after administration|AUC(0-t), The pharmacokinetic parameters of HSK21542 in plasma, From the start of administration to 168 hours after administration|AUC(0-∞), The pharmacokinetic parameters of HSK21542 in plasma, From the start of administration to 168 hours after administration|Tmax, The pharmacokinetic parameters of HSK21542 in plasma, From the start of administration to 168 hours after administration|t1/2, The pharmacokinetic parameters of HSK21542 in plasma, From the start of administration to 168 hours after administration | Secondary: The main metabolites of HSK21542, The main metabolites of HSK21542 in plasma, urine, feces, and dialysate, From the start of administration to 168 hours after administration|Adverse events (AEs), The incidence and severity of AEs, From after administration to the end of telephone follow-up
Sponsor/Collaborators: Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 6
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-10
Completion Date: 2024-02-27
Results First Posted:
Last Update Posted: 2024-08-20
Locations: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Jinan, Shandong, China
URL: https://clinicaltrials.gov/show/NCT06238388