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

NCT01358435 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-12-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Dr. Marcus Hompesch · Profil Institute for Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358435 on ClinicalTrials.gov