Intradermal Injections Clinical Trial
Official title:
An Open Label Study in Healthy Volunteers and Diabetes Mellitus Type II Subjects to Determine the Safety, Pharmacokinetics and Pharmacodynamics Profile of Insulin Injected by the MicronJet Device
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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