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

NCT ID: NCT00358553

Last Updated: 2007-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Tim Heise, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institute

Locations

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Profil

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CT 101-002

Identifier Type: -

Identifier Source: org_study_id

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