Ignite Creation Date:
2025-12-17 @ 9:11 PM
Ignite Modification Date:
2025-12-23 @ 9:58 PM
Study NCT ID:
NCT00752180
Status:
None
Last Update Posted:
2012-12-27 00:00:00
First Post:
2008-09-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single Dose,Single Centre,Double Blind,Crossover Study Comparing the Pharmacokinetic Profiles of Wockhardt's Insulin Human Injection, Soluble (Recombinant DNA Origin) for Injection and Actrapid in Type 1 Diabetics
Status:
None
Status Verified Date:
2012-12
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:
None
Brief Summary:
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well as assesses safety and local tolerability of the two insulin preparations in type 1 diabetics.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: