Insulin Loaded Orally Dissolved Films (Insulin-ODF)
Recruitment status was: Not yet recruiting
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.
|Healthy Volunteers||Drug: NPH-Insulin Injection Drug: Insulin loaded Orally Dissolved Films (insulin-ODF||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
|Experimental: Insulin loaded Orally Dissolved Films (insulin-ODF)||Drug: Insulin loaded Orally Dissolved Films (insulin-ODF|
|Active Comparator: Human Insulin Specific RIA Kit <5uCi||Drug: NPH-Insulin Injection|