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
  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:


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
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, see Learn About Clinical Studies.

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 August 26, 2014