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

> **NCT05248841** · PHASE1 · COMPLETED · sponsor: **Lannett Company, Inc.** · enrollment: 104 (actual)

## Conditions studied

- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** HEC-Glargine
- **DRUG:** US-Lantus

## Key facts

- **NCT ID:** NCT05248841
- **Lead sponsor:** Lannett Company, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-03-08
- **Primary completion:** 2022-08-31
- **Final completion:** 2022-08-31
- **Target enrollment:** 104 (ACTUAL)
- **Last updated:** 2022-09-15

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05248841

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05248841, "A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05248841. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
