Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.
Interventions
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-64 years (both inclusive) at the time of signing informed consent * Body mass index 18.5-28.0 kg/m\^2 (both inclusive) * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion criteria
* Known or suspected hypersensitivity to trial products or related products * Previous participation in this trial. Participation is defined as informed consent * Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin 338 concentration-time curve | From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin 338 concentration-time curve | From 0 to 288 hours after a single dose (SD) |
| Maximum observed serum insulin 338 concentration | From 0 to 288 hours after a single dose (SD) |
| Area under the plasma capric acid concentration-time curve | From 0 to 24 hours after a single dose |
| Maximum observed plasma capric acid concentration | From 0 to 24 hours after a single dose |
Countries
Germany
Outcome results
None listed