NCT01358435

Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

Randomized,Single Center,Double Blind,Two-period,Crossover Glucose Clamp Trial Study to Test Bioequivalence Between Two Recombinant Human Mixed Insulins-Wockhardt's Human/Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (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 70/30 to Novolin® 70/30 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 70N/30R and Novolin 70/30.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 Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	30% Regular Insulin Human Neutral and 70%Isophane Insulin	Total Dose per subject is 0.4 IU/Kg given subcutaneously.
BIOLOGICAL	Novolin 70/30	Total Dose per subject is 0.4IU/Kg given Subcutaneously.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2011-05-23
• Last updated: 2012-12-27

Locations

1 site across 1 country: United States