NCT06050343

Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method

Comparative Study of the Pharmacokinetics and Pharmacodynamics of Rinsulin® R, Solution for Injection, 100 IU/ml (GEROPHARM LLC) and Humulin® Regular, Solution for Injection, 100 IU/ml (Eli Lilly) in Euglycemic Hyperinsulinemic Clamp Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France ", France) using the euglycemic hyperinsulinemic clamp method.

Detailed description

A double-blind, randomized, comparative, crossover study of the pharmacokinetics and pharmacodynamics of Rinsulin® R, solution for injection, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, solution for injection, 100 IU / ml (Lilly France, France) using euglycemic hyperinsulinemic clamp method on healthy volunteers

Conditions

• Bioequivalence
• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	Humulin® Regular	subcutaneous injection at a dose of 0.3 IU / kg
DRUG	Rinsulin® R	subcutaneous injection at a dose of 0.3 IU / kg

Timeline

• Start date: 2018-02-19
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2023-09-22
• Last updated: 2023-09-22

Locations

1 site across 1 country: Russia