Comparative Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 18, 2017

Primary Completion Date

October 24, 2017

Study Completion Date

October 24, 2017

Conditions
Bioequivalence
Interventions
DRUG

Rinsulin® mix 30/70

one subcutaneous injection at a dose of 0.4 IU/kg

DRUG

Humulin® M3

one subcutaneous injection at a dose of 0.4 IU/kg

Trial Locations (3)

117036

"National Medical Research Center of Endocrinology of the Ministry of Health of the Russian Federation", Moscow

194156

"National Medical Research Center in name of V.A. Almazov of the Ministry of Health of the Russian Federation", Saint Petersburg

197342

"LLC BioEk, Russian Federation", Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Geropharm

INDUSTRY