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

NCT02634528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2020-07-02

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 isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal. All participants will receive both study treatments on two separate dosing days.

Conditions

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)

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Julphar Gulf Pharmaceutical Industries

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Neuss, 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
2016-11-16
Primary Completion
2017-01-20
Completion
2017-01-20

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 NCT02634528 on ClinicalTrials.gov