Insulin Loaded Orally Dissolved Films (Insulin-ODF)
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|ClinicalTrials.gov Identifier: NCT01446120|
Recruitment Status : Unknown
Verified October 2011 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
|First Submitted Date ICMJE||September 15, 2011|
|First Posted Date ICMJE||October 5, 2011|
|Last Update Posted Date||October 5, 2011|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Insulin Loaded Orally Dissolved Films (Insulin-ODF)|
|Official Title ICMJE||Not Provided|
This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick (buccal) , Releasing the insulin to the circulation, while the film is dissolved..
Seven healthy volunteers will be randomly assigned to one of the following groups:
A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.
The study is designed a crossover, in which each group is treated 3-7 days of washout.
The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and exclusion criteria).
An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels, ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.
Blood Insulin and glucose levels will be evaluated at baseline, and after the following time points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be evaluated at baseline and after the following time points: 60,120,240, 360 minutes.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Condition ICMJE||Healthy Volunteers|
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT01446120|
|Other Study ID Numbers ICMJE||OFRI01-CTIL-HMO|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Hadassah Medical Organization|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Hadassah Medical Organization|
|Verification Date||October 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP