drugset / Trial / NCT05248841
A Study to Demonstrate Pharmacokinetic and Pharmacodynamic Biosimilarity Between HEC-Glargine and US-Lantus® in Healthy Male Volunteers
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2022-03-08
- Primary completion
- 2022-08-31
- Completion
- 2022-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HEC-Glargine | Unknown | 0.5 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.5 iu/kg | Subcutaneous |