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PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males

NCT04235439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-02-13

No results posted yet for this study

Summary

Primary objective:

To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan \& Lee Insulin Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference Products) in healthy male subjects

Secondary objectives:

To compare the PK and PD parameters of the three insulin lispro preparations

To evaluate the single dose safety and local tolerability of the three insulin lispro preparations

Conditions

Interventions

DRUG

Gan & Lee Insulin Lispro Injection

All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.

Sponsors & Collaborators

  • Gan and Lee Pharmaceuticals, USA

    lead INDUSTRY

Principal Investigators

  • Jia Lu, PhD · Gan & Lee Pharmaceuticals, USA

  • Leona Plum - Mörschel, Dr. med · Profil Mainz GmbH & Co KG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2019-07-03
Completion
2019-07-03
FDA Drug
Yes

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 NCT04235439 on ClinicalTrials.gov