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Pharmacokinetic/Pharmacokinetic and Safety Studies of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

NCT05954169 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-07-11

No results posted yet for this study

Summary

This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of SHR4640 tablets in subjects with moderate renal insufficiency and healthy subjects, and to explore the relationship between renal function (e.g., eGFR) and SHR4640 pharmacokinetic and pharmacodynamic parameters.

Conditions

  • Hyperuricemia

Interventions

DRUG

SHR4640

SHR4640 single-dose

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05954169 on ClinicalTrials.gov