752180
Last Update Posted: 2012-12-27
Recruiting has ended
All Genders accepted | 18 Years-45 Years |
28 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics
The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.
The purpose of this study is to test for bioequivalence based on the pharmacokinetic parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well as assesses safety and local tolerability of the two insulin preparations in type 1 diabetics.
Eligibility
Relevant conditions:
Diabetes
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov