NCT00772265

Comparative Glucose Clamp Study of Wockhardt's Human Isophane Insulin With Novolin N,in Healthy Subjects

A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.

Detailed description

The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.

Conditions

• Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Wosulin N	Total Dose per subject will be 0.4IU/Kg given Subcutaneously.
BIOLOGICAL	Novolin N	Total dose per subject will be 0.4 IU/Kg given Subcutaneously.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2008-10-15
• Last updated: 2012-12-27

Locations

1 site across 1 country: United States