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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00358553
First Posted: August 1, 2006
Last Update Posted: March 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baxter Healthcare Corporation
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358553


Locations
Germany
Profil
Neuss, Germany
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Tim Heise, MD Profil Institute
  More Information

ClinicalTrials.gov Identifier: NCT00358553     History of Changes
Other Study ID Numbers: CT 101-002
First Submitted: July 31, 2006
First Posted: August 1, 2006
Last Update Posted: March 13, 2007
Last Verified: March 2007

Keywords provided by Baxter Healthcare Corporation:
Human Volunteers

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs