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

NCT02631928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-08-02

No results posted yet for this study

Summary

This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.

Conditions

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

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Julphar Gulf Pharmaceutical Industries

    lead INDUSTRY

Principal Investigators

  • Ulrike Hövelmann, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631928 on ClinicalTrials.gov