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A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® in Type 1 Diabetes Mellitus Patients

NCT04101383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-09-24

No results posted yet for this study

Summary

Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)

Conditions

  • Clamp Study

Interventions

DRUG

RinGlar®

Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg

DRUG

Lantus®

Single subcutaneous administration of Lantus® in dose 0.6 Units/kg

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2018-02-16
Completion
2018-02-16

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 NCT04101383 on ClinicalTrials.gov