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Pharmacokinetics and Safety Study of Levornidazole Disodium Phosphate for Injection in Subjects With Renal Impairment and Normal Renal Impairment

NCT07033182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-24

No results posted yet for this study

Summary

To evaluate the pharmacokinetics and safety of a single intravenous dose of levornidazole disodium phosphate for injection in subjects with moderate and severe renal impairment and healthy subjects.

Conditions

  • Infections Caused by Anaerobic Bacteria
  • Renal Impairment

Interventions

DRUG

Levornidazole Disodium Phosphate for Injection

Single dose, IV

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Beijing Haisha Consulting Co., Ltd

    collaborator UNKNOWN

  • Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-04-07
Completion
2024-07-31

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 NCT07033182 on ClinicalTrials.gov