NCT04501250

Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

A Double-blinded, Randomized, Comparative, Crossover Pharmacokinetics Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using Method of Euglycemic Hyperinsulinemic Clamp on Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Geropharm · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using the euglycemic hyperinsulinemic clamp.

Detailed description

A double-blinded, randomized, comparative, crossover pharmacokinetics study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using method of euglycemic hyperinsulinemic clamp on healthy volunteers

Conditions

• Pharmacokinetics
• Bioequivalence

Interventions

Type	Name	Description
DRUG	Rinsulin NPH	subcutaneous injection at a dose of 0.4 IU/kg
DRUG	Humulin NPH	subcutaneous injection at a dose of 0.4 IU/kg

Timeline

• Start date: 2017-10-23
• Primary completion: 2018-01-01
• Completion: 2018-05-21
• First posted: 2020-08-06
• Last updated: 2020-08-06

Locations

1 site across 1 country: Russia