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

PHASE1CompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

October 12, 2018

Study Completion Date

October 12, 2018

Conditions
HIV-1-infection
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

Trial Locations (2)

125315

"Private non - governmental health care institution Scientific Clinical Center of the open joint - stock company Russian Railways", Moscow

143965

Central City Clinical Hospital Reutov, Reutov

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Viriom

INDUSTRY