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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral insulin and placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oshadi Oral Insulin | Drug | Oral insulin single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events occurrence | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the glucose lowering effect of Oshadi Oral Insulin | 12 hours following administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanna Levy, Dr. | Oshadi Drug Administration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center | Zrifin | Beer-Yaakov | 70300 | Israel |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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