NCT01400789

Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).

Detailed description

The primary objective of this study is assess the bioequivalence of two premixed formulations of insulin Lispro, Humalog Mix50/50® and ListroMix 50/50® 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.

Conditions

• Bioequivalence in Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Insulin Lispro	Dosage form- Subcutaneous Injection

Timeline

• First posted: 2011-07-22
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States