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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
July 31, 2006
August 1, 2006
March 13, 2007
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Complete list of historical versions of study NCT00358553 on ClinicalTrials.gov Archive Site
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A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin
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The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.
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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
Drug: Insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00358553
CT 101-002
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Baxter Healthcare Corporation
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Principal Investigator: Tim Heise, MD Profil Institute
Baxter Healthcare Corporation
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP