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A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment - Trial NCT05916573

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.

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NCT05916573
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov • NCT05916573
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A Study to Evaluate the Pharmacokinetics of HSK16149 in Subjects With Renal Impairment

Study Focus

Renal Impairment

HSK16149

Interventional

drug

Sponsor & Location

Haisco Pharmaceutical Group Co., Ltd.

Chengdu, China

Timeline & Enrollment

Phase 1

Dec 12, 2022

Apr 26, 2023

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT05916573

Non-Device Trial