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NCT05497297

A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment

An Open-label, Single-dose Study to Assess the Pharmacokinetics of HSK7653 Tablets in Subjects With Varying Degrees of Renal Impairment Compared to the Control Subjects With Normal Renal Function
Haisco Pharmaceutical Group Co., Ltd.·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
HSK7653 tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Haisco Pharmaceutical Group Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
Aug 04, 2022
End date
Nov 03, 2022
Enrollment
64 participants
Primary outcome

Cmax,AUC0-t,AUC0-inf

Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics, pharmacodynamics
 and safety of HSK7653 in subjects with mild, moderate, severe renal impairment and subjects
 with kidney failure compared to the matched control subjects with normal renal function.

ICD-10 classifications
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05497297
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05497297 through Pure Global AI's free database. This Phase 1 trial is sponsored by Haisco Pharmaceutical Group Co., Ltd. and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.