Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

December 12, 2022

Study Completion Date

December 12, 2022

Conditions
Healthy Volunteers
Interventions
BIOLOGICAL

Biocon's Human Insulin R U-500

Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).

BIOLOGICAL

Humulin® R U-500 (US Reference Product)

Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)

Trial Locations (1)

D-41460

Profil Institut für Stoffwechselforschung GmbH 9, Neuss

All Listed Sponsors
collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

lead

Biocon Limited

INDUSTRY