CClinicalTrials.gg
CompletedNCT00358553Updated Mar 13, 2007

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

A Phase 1 interventional study of Insulin in Healthy, sponsored by Baxter Healthcare Corporation. Completed at 1 site in Germany. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-03-13.

Sponsored by Baxter Healthcare Corporation · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Human Volunteers
03

In context

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 78 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Male Subjects
  • Age between 18 and 40 years of age

Exclusion criteria

Exclusion Criteria:

  • History of Diabetes
  • Subjects with clinically significant active disease
  • Known allergy to insulin
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)

Interventions

  • DrugInsulin
06

Study locations

1 site
  • Profil
    Neuss, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00358553
Lead sponsor
Baxter Healthcare Corporation
First posted
Aug 1, 2006
Last update
Mar 13, 2007

Study contacts

Tim Heise, MD
principal investigator · Profil Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion