Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01400789

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

Bioequivalence in Healthy Subjects Clinical Trial

Clinical Trial 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).

Clinical Trial 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. ;

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
Clinical Trial Details
NCT number NCT01400789
Study type Interventional
Source Wockhardt
Contact
Status Withdrawn
Phase Phase 1
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT01400802 - Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy Subjects Phase 1
Withdrawn NCT01399255 - Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects Phase 1