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

NCT06050343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-22

No results posted yet for this study

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.

Conditions

  • Bioequivalence
  • Therapeutic Equivalency

Interventions

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

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
2018-02-19
Primary Completion
2018-05-04
Completion
2018-05-04

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 NCT06050343 on ClinicalTrials.gov