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A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle

NCT00602914 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-05-10

No results posted yet for this study

Summary

The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.

Conditions

  • Intradermal Injections

Interventions

DEVICE

MicronJet

The micronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the skin). In this study the MicronJet will be used to inject insulin vs. a convention needle injection.

DEVICE

MicronJet

MicronJet, Intradermal Injection

Sponsors & Collaborators

  • NanoPass Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Itamar Raz, MD · Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-12-31
Completion
2009-07-31

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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 NCT00602914 on ClinicalTrials.gov