NCT00358553

Brief Summary

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
Last Updated

March 13, 2007

Status Verified

March 1, 2007

First QC Date

July 31, 2006

Last Update Submit

March 12, 2007

Conditions

Healthy

Keywords

Human Volunteers

Interventions

InsulinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male Subjects
  • Age between 18 and 40 years of age

You may not qualify if:

  • History of Diabetes
  • Subjects with clinically significant active disease
  • Known allergy to insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil

Neuss, Germany

Location

MeSH Terms

Interventions

Insulin

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Tim Heise, MD

    Profil Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Last Updated

March 13, 2007

Record last verified: 2007-03

Locations

DE(1)