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An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone as a Single-Dose Administration or a Treatment Course in Healthy Volunteers

NCT03205462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-07-24

No results posted yet for this study

Summary

The current Phase I clinical trial has been developed to assess the safety and tolerability of the Fluorothyazinone drug used as a single-dose administration and a treatment course in healthy volunteers. This dose-escalation trial will be conducted with sequential enrollment of volunteers.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Fluorothyazinone 300 mg

Fluorothyazinone in a dosage of 300 mg (1 tablet)

DRUG

Fluorothyazinone 600 mg

Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose

DRUG

Fluorothyazinone 3900 mg

The total dose of Fluorothyazinone per treatment course is 3900 mg.

Sponsors & Collaborators

  • Center of Pharmaceutical Analytics LLC

    collaborator INDUSTRY

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2017-12-08
Completion
2017-12-15

Countries

  • Russia

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 NCT03205462 on ClinicalTrials.gov