Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

November 16, 2016

Primary Completion Date

January 20, 2017

Study Completion Date

January 20, 2017

Conditions
Diabetes Mellitus
Interventions
DRUG

Julphar Insulin N (human isophane insulin)

investigational insulin: Julphar N (human isophane insulin), biosimilar

DRUG

Huminsulin® Basal (NPH, human isophane insulin)

marketed reference product: Huminsulin® Basal (NPH, human isophane insulin)

Trial Locations (1)

41460

Profil Neuss GmbH, Neuss

All Listed Sponsors
collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

lead

Julphar Gulf Pharmaceutical Industries

INDUSTRY