Comparison of Two NN1250 Formulations in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | October 2009 |
A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects
This trial was conducted in North America. The aim of this clinical trial was to investigate
if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the
body.
if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the
body.
Inclusion Criteria:
- Considered generally healthy upon completion of medical history, physical
examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 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 screening
- 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
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