A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects
- Registration Number
- NCT01623375
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description s.c. insulin degludec - i.v. insulin degludec -
- Primary Outcome Measures
Name Time Method Area under the serum insulin degludec concentration-of s.c. administration From 0 to infinity after single dose Area under the serum insulin degludec concentration-of i.v. administration From 0 to infinity after single dose
- Secondary Outcome Measures
Name Time Method Terminal half-life for insulin degludec From 0 to 30 hours after single dose Volume of distribution of insulin degludec, estimated during the terminal phase From 0 to 30 hours after single dose