Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in Healthy Subjects

Viriom2 sites in 1 country140 target enrollmentJune 1, 2018

ConditionsHIV-1-infection

InterventionsVM-1500FDC Elpida®Truvada®

DrugsVM-1500FDC Elpida®Truvada®

Overview

Phase: Phase 1
Intervention: VM-1500FDC
Conditions: HIV-1-infection
Sponsor: Viriom
Enrollment: 140
Locations: 2
Primary Endpoint: Plasma concentration of VM1500A
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients. Thus, the purpose of this combination is to simplify the dosage regimen and improve patient compliance

Registry

clinicaltrials.gov

Start Date

June 1, 2018

End Date

October 12, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Viriom

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
•Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
•Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
•A negative result in tests for alcohol and drugs;
•The subject's consent to use adequate contraception methods during the study and 3 month after end of study: condom with spermicide (foam, gel, cream, suppositories);
•Signed the Participant Explanation Sheet and the Informed Consent Form.

Exclusion Criteria

•Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
•Variables of standard laboratory and instrumental parameters are beyond the normal limits Variables of standard laboratory and instrumental parameters are beyond the normal limits (taking into account the acceptable limits of laboratory parameters);
•Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
•Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
•Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to screening;
•Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
•An unstable sleep structure (e.g., night work, sleep disorders, insomnia, recent return from another time zone, etc.), extreme physical activity (e.g. weight lifting), a special diet (e.g. vegetarian, vegan);
•Signs of alcohol (taking more than 10 units of alcohol per week ) or drug addiction; alcohol or drugs consumption within 4 days prior to screening; cigarettes smoking 3 months prior to screening; positive drug and/or alcohol test;
•Burdened allergic medical history (including drug intolerance and food allergy);
•Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;