An Open-label Clinical Study of the Pharmacokinetics and Safety of Elsulfavirine, 200 mg Tablets, With Single and Multiple Oral Administration in Healthy Volunteers

NCT05148754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-12-09

No results posted yet for this study

Summary

An open-label clinical study of the pharmacokinetics and safety of Elsulfavirine, 200 mg tablets, with single and multiple oral administration in healthy volunteers.

Conditions

Interventions

DRUG

Elsulfavirine

Elsulfavirin 200 mg tablets.

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Irina Rodyukova, PhD · V. P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-01-23
Primary Completion
2021-08-15
Completion
2021-08-16

Countries

  • Russia

Study Locations

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Entities

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 NCT05148754 on ClinicalTrials.gov