NCT01400802

Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® 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• Status: Withdrawn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 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.

Conditions

• Bioequivalence in Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Insulin Lispro	Dosage form- Subcutaneous Injection

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2011-07-22
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States