A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin

This study has been completed.

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00358553

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Insulin	Phase I

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Male Subjects
Age between 18 and 40 years of age

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358553

Locations

Germany
Profil
Neuss, Germany

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Tim Heise, MD

Profil Institute

More Information

Study ID Numbers:	CT 101-002
Study First Received:	July 31, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00358553
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Baxter Healthcare Corporation:

Human Volunteers

Study placed in the following topic categories:

Healthy
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009