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Sponsored by: |
NanoPass Technologies Ltd |
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Information provided by: | NanoPass Technologies Ltd |
ClinicalTrials.gov Identifier: | NCT00602914 |
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
Condition | Intervention | Phase |
---|---|---|
Intradermal Injections |
Device: MicronJet |
Phase 0 |
Study Type: | Interventional |
Study Design: | Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
10 healthy volunteers will receive 0.1 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order
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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
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2: Experimental
10 Type II DM subject will receive 0.2 U/kg. Once administered with a conventional needle (SQ) and then with MicronJet needle (ID) in a randomized order
|
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
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
A. Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
B. Type 2 diabetic patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Itamar Raz, MD | 972-2-677-8021 | ntv502@netvision.net.il |
Israel | |
Hadassha Medical Organization | Recruiting |
Jerusalem, Israel |
Principal Investigator: | Itamar Raz, MD | Head, Diabetes Unit, Hadassah Medical Organization, Jerusalem, Israel |
Responsible Party: | Nanopass Technologies Ltd. ( Ofer Sharon, MD ) |
Study ID Numbers: | NP-1-001 |
Study First Received: | December 30, 2007 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00602914 |
Health Authority: | Israel: Ethics Commission; Israel: Ministry of Health |
MicronJet (microneedles) Intradermal |
Diabetes Mellitus, Type 2 Diabetes Mellitus Healthy Insulin |