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

NCT00719108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-12-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Wosulin R

Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

BIOLOGICAL

Actrapid

Total dose per subject will be 0.3 IU/Kg given IV over 5 hrs.

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Marcus Hompesch, MD · Profil Institute of Clinical Research

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
2008-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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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 NCT00719108 on ClinicalTrials.gov