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A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers

NCT05248841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-09-15

No results posted yet for this study

Summary

This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.

Conditions

Interventions

DRUG

HEC-Glargine

Subjects will receive 0.5 IU/kg of HEC-Glargine subcutaneously as a single morning dose on Day 1.

DRUG

US-Lantus

Subjects will receive 0.5 IU/kg of Lantus subcutaneously as a single morning dose on Day 1.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • FARMOVS (Pty) Ltd

    collaborator UNKNOWN

  • Lannett Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT05248841 on ClinicalTrials.gov