Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics of Julphar Insulin R and Huminsulin® Normal

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Diabetes Mellitus
Interventions
DRUG

Julphar Insulin R (soluble human insulin, biosimilar)

investigational insulin, Julphar Insulin R (soluble human insulin)

DRUG

Huminsulin® Normal (soluble human insulin, reference)

marketed product, Huminsulin® Normal (soluble human insulin

Trial Locations (1)

41460

Profil Institut für Stoffwechselforschung GmbH, Neuss

Sponsors
All Listed Sponsors
collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

collaborator

Parexel

INDUSTRY

lead

Julphar Gulf Pharmaceutical Industries

INDUSTRY