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Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers

NCT07110441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-01-16

No results posted yet for this study

Summary

A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects

Conditions

  • Acute-on-Chronic Liver Failure

Interventions

DRUG

Single Dose G1090N

Subjects will receive single ascending doses of G1090N up to 1200mg.

DRUG

Multiple dosing of G1090N

Subjects will receive multiple ascending doses of G1090N up to 1200mg twice daily for 7 consecutive days.

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2025-12-01
Completion
2025-12-03
FDA Drug
Yes

Countries

  • United States

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 NCT07110441 on ClinicalTrials.gov