Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III

PHASE1CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Diabetes Mellitus
Interventions
DRUG

human biphasic insulin

investigational insulin, biosimilar human insulin suspension of 30% normal insulin and 70% basal protamined insulin

DRUG

human biphasic insulin, reference

marketed product, human insulin suspension of 30% normal insulin and 70% basal (NPH) insulin

Trial Locations (1)

41460

Profil Institut für Stoffwechselforschung GmbH, Neuss

All Listed Sponsors
collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

lead

Julphar Gulf Pharmaceutical Industries

INDUSTRY