NCT05248841

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Lannett Company, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-08
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2022-02-21
• Last updated: 2022-09-15

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study