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

NCT02634515 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-12-24

No results posted yet for this study

Summary

This study in healthy volunteers aimed to demonstrate similar PK and PD properties of the new short-acting human soluble insulin, Julphar Insulin R, and the already approved reference insulin, Huminsulin® Normal. The trial participants received both study treatments on two separate dosing days.

Conditions

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

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • Julphar Gulf Pharmaceutical Industries

    lead INDUSTRY

Principal Investigators

  • Ulrike Hövelmann · 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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

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 NCT02634515 on ClinicalTrials.gov