Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.
Interventions
A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Japanese * Body Mass Index (BMI) of 19-27 kg/m\^2 (both inclusive) * Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive * Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator
Exclusion criteria
* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s) * Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator * Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator * Hepatitis B or C, or HIV (human immunodeficiency virus) * Use of prescription drugs within 2 weeks preceding the screening * Use of non-prescription drugs, except routine vitamins or drugs that may not * Blood donation of more than 1150 mL within the last 12 months * Subjects with a first degree relative with diabetes mellitus * History of or presence of diabetes * History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder * Previous history of serious allergy or anaphylactic reaction * Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse * Subjects who smoke more than 5 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70) | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, time to maximum insulin aspart concentration | — |
| t½, terminal elimination half life | — |
| Mean residence time (MRT) | — |
| Cmax, maximum insulin aspart concentration | — |
| Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) | — |
| Adverse events | — |
| Area under the curve from time 0 to infinity (0-∞) | — |
Countries
Japan
Outcome results
None listed