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COMPLETED
NCT07906197
PHASE1

A Mass Balance Study on [14C]Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects

Sponsor: Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

To quantitatively analyze the total radioactivity in excreta from healthy male subjects following a single intravenous infusion of \[14C\]levornidazole disodium phosphate, and to semi-quantitatively estimate the recovery of 14CO₂ in exhaled breath, thereby obtaining the human radioactivity recovery data and identifying the major routes of excretion; To analyze the radioactive metabolite profiles in human plasma, urine, and feces from healthy male subjects following a single intravenous infusion of \[14C\]levornidazole disodium phosphate, to identify the major metabolites, and to determine the metabolic pathways and elimination routes of levornidazole disodium phosphate in humans; To quantitatively analyze the total radioactivity in whole blood and plasma from healthy male subjects following a single intravenous infusion of \[14C\]levornidazole disodium phosphate, to obtain the pharmacokinetic parameters of total radioactivity in plasma, and to investigate the distribution of total radioactivity between whole blood and plasma.

Official title: Study on [14C] Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-10-30

Completion Date

2025-02-14

Last Updated

2026-10-30

Healthy Volunteers

Yes

Interventions

DRUG

Levornidazole Disodium Phosphate for Injection

D1: 0.5g/30 µCi \[14C\] levornidazole disodium phosphate Single dose

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, China