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

Type 2 Diabetes Mellitus Clinical Trial

Official title:
A Single Center, Single-dose, Double-blind, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between HEC-Glargine and US-Lantus® Using the Euglycemic Clamp Technique in Healthy Male Adult Volunteers

Clinical Trial 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.

Clinical Trial Description

This will be a double-blind, single-dose, randomized, two-period, two-treatment, two-sequence crossover clamp study performed at a single study center. The study population consists of healthy adult male subjects. The study will comprise of: - A screening period: maximum 28 days prior to first dose administration. - Admission: Subjects will be admitted to the study center on Day -1 - Two Treatment Periods (Treatment Periods 1 and 2): Subjects will be randomized to either of the 2 treatment sequences (AB or BA) on Day 1 of Treatment Period 1 to receive either test or reference product as per randomization schedule in a 1:1 ratio. - Treatment A (Test Formulation): HEC-Glargine - Treatment B (Reference Formulation): US-Lantus® On Day 1 of each Treatment Period, the study drug or reference product will be administered as a single morning dose to subjects in a fasting state. There will be a wash-out period of at least 7 calendar days. Each subject will receive both test and reference products in a crossover pattern over Treatment Periods 1 and 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05248841
Study type Interventional
Source Lannett Company, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 8, 2022
Completion date August 31, 2022
View Details
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