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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

NCT04501250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-08-06

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics
  • Bioequivalence

Interventions

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Sergei Mr Noskov, AP of medicine · Yaroslavl City Clinical Hospital No. 3

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2018-01-01
Completion
2018-05-21

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04501250 on ClinicalTrials.gov