Healthy Volunteers Clinical Trial
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..
Primary endpoint:
1. The Cmax (Maximum Concentration of insulin in mg).
2. Tmax (the time to Cmax in minutes)
3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.
Secondary endpoints:
1. The glucose and C-peptide levels during six hours of the trial. (mg)
2. The safety of the treatment in a descriptive manner by recording all adverse events in
the study population.
Methods
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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