Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed
Interventions
A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician) * Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)
Exclusion criteria
* Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician) * A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject * Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry) * Not able or willing to refrain from smoking during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve from 0 to 24hours | 24 hours profile after single dose of trial drug |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve between different time intervals | 24 hours profile after single dose of trial drug |
| Maximum observed serum insulin aspart concentration | 24 hours profile after single dose of trial drug |
| Number of adverse events. | After 3-10 days of treatment |
| Number of hypoglycaemic events | After 3-10 days of treatment |
Countries
China
Outcome results
None listed