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Trial · NCT07906197

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

NCT07906197, Phase 1, Completed, Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Mass Balance Study on [14C]Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects. Trials, record NCT07906197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07906197

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Mass Balance Study on [14C]Levornidazole Disodium Phosphate for Injection in Healthy Chinese Adult Male Subjects
NCT number
NCT07906197
Status
Completed
Phases
Phase 1
Enrollment
6 participants, actual
Lead sponsor
Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd
Conditions
Mass Balance Study
Interventions
Levornidazole Disodium Phosphate for Injection
First posted
2026-10-30
Last updated
2026-10-30

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCumulative Percent Recovery of Total Radiocarbon (14C)From Day 1 to Day 10Percentage recovery of total radioactivity (14C) in urine, feces, and exhale was determined based on total administered dose.
PrimaryPercentage of Metabolite Detected in Plasma ,Urine, FecesFrom Day 1 to Day 10The percentage of major metabolites detected in plasma urine, feces following \[14C\]levornidazole disodium phosphate single dose administration
PrimaryArea Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of levornidazoleFrom Day 1 to Day 10AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PrimaryArea Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of levornidazoleFrom Day 1 to Day 10AUCinf is defined as the concentration of drug extrapolated to infinite time.
PrimaryMaximum Observed Plasma Concentration (Cmax) of levornidazoleFrom Day 1 to Day 10Cmax is defined as the maximum concentration of drug.
SecondaryClearance (CL) of levornidazoleFrom Day 1 to Day 10CL is defined as the clearance following administration of the drug.
SecondaryThe Volume of Distribution (Vd) of levornidazoleFrom Day 1 to Day 10Vd is defined as the volume of distribution of the drug.
SecondaryTime of Maximum Observed Plasma Concentration (Tmax) of levornidazoleFrom Day 1 to Day 10Tmax is defined as the time (observed time point) of Cmax.
SecondaryApparent Terminal Elimination Half-life (t1/2) of levornidazoleFrom Day 1 to Day 10
SecondaryMean Residence Time (MRT0-t) of levornidazoleFrom Day 1 to Day 10

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07906197

GET https://conductscience.org/api/trials/v1/NCT07906197/registered