MedTrace Logo

Comparative Study of PK and BE of VM-1500FDC (Fixed-dose Combination) and Elpida® With Truvada® сo-administrated 1 Daily Fasting in Healthy Subjects

NCT03706924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-10-30

No results posted yet for this study

Summary

Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.

Conditions

Interventions

DRUG

VM-1500FDC

A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets

DRUG

Elpida®

Elpida®, capsules, elsulfavirine 20 mg

DRUG

Truvada®

Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Elena Mazygula, PhD · Private non - governmental health care institution "Scientific Clinical Center of the open joint - stock company Russian Railways"

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-10-12
Completion
2018-10-12

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT03706924 on ClinicalTrials.gov