Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-29 @ 6:39 AM
Study NCT ID:
NCT01114750
Status:
SUSPENDED
Last Update Posted:
2010-10-05
First Post:
2010-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Absorption of Peroral Insulin in Dextran Matrix (ORA3)
Sponsor:
Bows Pharmaceuticals AG
Organization:
Study Overview
Official Title:
A Placebo-controlled Study of Insulin Absorption in Healthy Volunteers After Single-dose Oral Administration of Insulin in Dextran Matrix
Status:
SUSPENDED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORA3
Brief Summary:
A pharmacokinetic study on the absorption of perorally delivered insulin in dextran matrix after single dose administration.
Detailed Description:
The study is a single blind, cross over study where each subject will receive a a single active dose (200 IU) of insulin in dextran matrix and placebo on two different experimental days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: