Insulin Loaded Orally Dissolved Films (Insulin-ODF)
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..
- The Cmax (Maximum Concentration of insulin in mg).
- Tmax (the time to Cmax in minutes)
- AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.
- The glucose and C-peptide levels during six hours of the trial. (mg)
- The safety of the treatment in a descriptive manner by recording all adverse events in the study population.
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.
Drug: NPH-Insulin Injection
Drug: Insulin loaded Orally Dissolved Films (insulin-ODF
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
- Blood Insulin [ Designated as safety issue: No ]To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.
- glucose and C-peptide levels [ Designated as safety issue: No ]Evaluating the glucose and C-peptide levels during six hours of the trial.
- hypoglycemia and irritation. [ Designated as safety issue: Yes ]All the examinations will be done in the presence of a physician along with a medical assistant. Hypoglycemia and irritation are the main adverse event that we anticipate in this study. In any such event the proper reporting and treatment will be administrated, while these subjects will be followed up for a further 1 month
|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|