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

NCT00596063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-12-27

No results posted yet for this study

Summary

The purpose of this study is the comparative evaluation of the pharmacokinetics and pharmacodynamics of two recombinant regular human insulin injections administered subcutaneously in healthy volunteers under the conditions of euglycemic clamp.

Conditions

Interventions

BIOLOGICAL

Wosulin R

Penfill cartridges; Single Dose, 0.2 IU/ kg;

BIOLOGICAL

Novolin R

Penfill cartridges; Single Dose, 0.2 IU/ kg;

Sponsors & Collaborators

  • Wockhardt

    lead INDUSTRY

Principal Investigators

  • Linda Morrow, M.D · Profil Institute for Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

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 NCT00596063 on ClinicalTrials.gov