Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects

Bioequivalence in Healthy Subjects Clinical Trial

Status Withdrawn

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bioequivalence in Healthy Subjects

• NCT number: NCT01400802
• Study type: Interventional
• Source: Wockhardt
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 2011
• Completion date: June 2012