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

PHASE1CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

March 8, 2022

Primary Completion Date

August 31, 2022

Study Completion Date

August 31, 2022

Conditions
Type 1 Diabetes MellitusType 2 Diabetes Mellitus
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.

Trial Locations (1)

9301

FARMOVS Clinical Research Organization, Bloemfontein

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

collaborator

FARMOVS (Pty) Ltd

UNKNOWN

lead

Lannett Company, Inc.

INDUSTRY