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

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.
 
ClinicalTrials.gov Identifier: NCT00358553
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : March 13, 2007
Sponsor:
Information provided by:
Baxter Healthcare Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Insulin Phase 1

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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
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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
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Germany
Profil
Neuss, Germany
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Tim Heise, MD Profil Institute
More Information
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ClinicalTrials.gov Identifier: NCT00358553    
Other Study ID Numbers: CT 101-002
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: March 2007
Keywords provided by Baxter Healthcare Corporation:
Human Volunteers
Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs