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A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study
The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.
Details
| Lead sponsor | Oshadi Drug Administration |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 8 |
| Start date | 2010-10 |
| Completion | 2011-02 |
Conditions
- Diabetes
Interventions
- Oshadi Oral Insulin
Primary outcomes
- Adverse events occurrence — one month
Countries
Israel