Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01400802
Status:
WITHDRAWN
Last Update Posted:
2013-01-25
First Post:
2011-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects
Sponsor:
Wockhardt
Organization:
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
Detailed Description:
The aim of this study is to assess the bioequivalence of two insulin analog mixtures: Listro Mix75/25® and Humalog Mix75/25® in healthy subjects based on the pharmacokinetic parameter (PK)AUC (INS-LIS 0-20h) and the pharmacodynamic parameter (PD)AUC (GIR 0-20h) and also assess the safety and local tolerability of the two insulin preparations.
Study Oversight
Has Oversight DMC:
False
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?: