NCT00596063

Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Novolin R, in Healthy Subjects.

A Randomized, Single Center, Double Blind, Two Period, Crossover Glucose Clamp Study to Test for Bioequivalence Between Two Recombinant Human Soluble Insulins- Wockhardts Insulin Human Regular for Injection and Novolin R in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.

Detailed description

A comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers. It is a crossover study. The subjects shall be administered single doses of each insulin during two separate visits under the conditions of euglycemic clamp.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Wosulin R	Penfill cartridges; Single Dose, 0.2 IU/ kg;
BIOLOGICAL	Novolin R	Penfill cartridges; Single Dose, 0.2 IU/ kg;

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-01-16
• Last updated: 2012-12-27

Locations

2 sites across 1 country: United States