Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients

NCT01120912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-04-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Oshadi Oral Insulin

Oral insulin single administration

Sponsors & Collaborators

  • Oshadi Drug Administration

    lead INDUSTRY

Principal Investigators

  • Hanna Levy, Dr. · Oshadi Drug Administration

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Israel

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120912 on ClinicalTrials.gov