Pure Global
NCT05916573

A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

Haisco Pharmaceutical Group Co., Ltd.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
HSK16149
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Haisco Pharmaceutical Group Co., Ltd.
Location
Chengdu, China
Timeline & enrollment
Phase
Phase 1
Start date
Dec 12, 2022
End date
Apr 26, 2023
Enrollment
32 participants
Primary outcome

Cmax,AUC0-t,AUC0-inf

Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of
 HSK16149 in subjects with mild, moderate and severe renal impairment 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
NCT05916573
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05916573 through Pure Global AI's free database. This Phase 1 trial is sponsored by Haisco Pharmaceutical Group Co., Ltd. and is currently Completed. The study focuses on Renal Impairment. Target enrollment is 32 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.