drugset / Trial / NCT01358435

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

NCT01358435 ↗

Phase 1 Completed 53 enrolled Wockhardt
RandomizedCrossoverQuadruple-blindHealth-services research

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.

Timeline

Start
2011-01
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Novolin 70/30 Protein / enzyme biologic 0.4 iu/kg Subcutaneous
Subject Wosulin 70N/30R Protein / enzyme biologic 0.4 iu/kg Subcutaneous

Indications