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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
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.
Details
| Lead sponsor | Wockhardt |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 53 |
| Start date | 2011-01 |
| Completion | 2011-05 |
Conditions
- Diabetes Mellitus
Interventions
- 30% Regular Insulin Human Neutral and 70%Isophane Insulin
- Novolin 70/30
Primary outcomes
- Mean AUC0-24h and Cmax — Visit 2 and 3
Countries
United States