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A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment - Trial NCT05497297

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.

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NCT05497297
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT05497297
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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

Study Focus

Renal Impairment

HSK7653 tablets

Interventional

drug

Sponsor & Location

Haisco Pharmaceutical Group Co., Ltd.

Beijing, China

Timeline & Enrollment

Phase 1

Aug 04, 2022

Nov 03, 2022

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 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

NCT05497297

Non-Device Trial