Insulin Loaded Orally Dissolved Films (Insulin-ODF)

NCT01446120 | Unknown Phase 1

• 1 other identifier: OFRI01-CTIL-HMO
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.The Cmax (Maximum Concentration of insulin in mg).
2. 2.Tmax (the time to Cmax in minutes)
3. 3.AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.
4. 4.The glucose and C-peptide levels during six hours of the trial. (mg)
5. 5.The safety of the treatment in a descriptive manner by recording all adverse events in the study population.

Conditions

Healthy Volunteers

Keywords

this is phase one study. The study population are healthy volunteers.

Outcome Measures

Primary Outcomes (1)

• Blood Insulin

  To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.

Secondary Outcomes (2)

• glucose and C-peptide levels

• hypoglycemia and irritation.

Study Arms (2)

Insulin loaded Orally Dissolved Films (insulin-ODF)

EXPERIMENTAL

Drug: Insulin loaded Orally Dissolved Films (insulin-ODF

Human Insulin Specific RIA Kit <5uCi

ACTIVE COMPARATOR

Drug: NPH-Insulin Injection

Interventions

NPH-Insulin Injection DRUG

Human Insulin Specific RIA Kit <5uCi

Insulin loaded Orally Dissolved Films (insulin-ODF DRUG

Insulin loaded Orally Dissolved Films (insulin-ODF)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent.
• \<BMI\<30

You may not qualify if:

• Smokers.
• Known mouth cavity, gums or gastrointestinal disease.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Interventions

Insulin, Isophane

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: October 5, 2011
• Last Updated: October 5, 2011

Record last verified: 2011-10