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

2014-07-24 14:19:05 | BioPortfolio

Summary

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

Description

Administration of insulin to the skin has many potential advantages including improved kinetics and reduced pain. Today, insulin is injected to the SQ space, using, in most cases, various devices incorporating standard metal needles and usually causing considerable pain and discomfort to the patients. NanoPass has developed a microneedle based needle substitute for intradermal injections. This device requires minimal expertise and is expected to cause minimal or no pain during injections.

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of insulin Novorapid® (Novo Nordisk) injected via the MicronJet device intradermally, to a conventional needle injected to the SQ space.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Intradermal Injections

Intervention

MicronJet, MicronJet

Location

Hadassha Medical Organization
Jerusalem
Israel

Status

Recruiting

Source

NanoPass Technologies Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:19:05-0400

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Medical and Biotech [MESH] Definitions

The forcing into the skin of liquid medication, nutrient, or other fluid through a hollow needle, piercing the top skin layer.

A nevus in which nests of melanocytes are found in the dermis, but not at the epidermal-dermal junction. Benign pigmented nevi in adults are most commonly intradermal. (Stedman, 25th ed)

Injections introduced directly into localized lesions.

Injections into the lymph nodes or the lymphatic system.

Injections made into a vein for therapeutic or experimental purposes.

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