A Comparison Between Two Formulations of NN5401 in Healthy Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:May 2010
End Date:August 2010

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Trial Summary
Trial Overview
Inclusion Criteria

A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects

This trial is conducted in the United States of America (USA). The aim of the trial is to
compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in
healthy subjects.


Inclusion Criteria:

- Considered generally healthy upon completion of medical history, physical
examination, vital signs and electrocardiogram (ECG), as judged by the physician

- Body mass index between 18.0 and 27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to trial start

- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)

- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
We found this trial at
1
site
Novo Nordisk Clinical Trial Call Center
Chula Vista, California 91911
?
mi
from
Chula Vista, CA
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