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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00358553
First received: July 31, 2006
Last updated: March 12, 2007
Last verified: March 2007
History of Changes
  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: Open Label

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

  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

No publications provided

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

Keywords provided by Baxter Healthcare Corporation:
Human Volunteers

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

ClinicalTrials.gov processed this record on May 16, 2013