Overview

A Comparison Between Two Formulations of NN5401 in Healthy Subjects

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
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