Status:
COMPLETED
Comparison of Two Identical NN1250 Formulations in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug exposure to the body.
Eligibility Criteria
Inclusion
- Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m\^2 (both inclusive)
Exclusion
- 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
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01193387
Start Date
August 1 2010
End Date
November 1 2010
Last Update
November 27 2013
Active Locations (1)
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1
Neuss, Germany, 41460