NCT07033182

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

An Open-Label, Parallel, Single-Dose Study to Assess the Pharmacokinetics and Safety of Levornidazole Disodium Phosphate for Injection in Subjects With Varying Degrees of Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Levornidazole Disodium Phosphate for Injection	Single dose, IV

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-04-07
• Completion: 2024-07-31
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China