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

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

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
Drug: Insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Baxter Healthcare Corporation:


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

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

Neuss, Germany
Sponsors and Collaborators
Baxter Healthcare Corporation
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:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014