Healthy Participants
Conditions
Brief summary
In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.
Interventions
DRUGSemaglutide
Oral administration
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
Key inclusion criteria: * Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening. * Considered to be generally 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. Key
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve | From 0 to 24 hours after dosing on day 80 and 90 | Measured in hour\*nanomoles per liter (h\*nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration | From 0 to 24 hours after dosing on day 80 and 90 | Measured in nanomoles per liter (nmol/L). |
| Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration | From 0 to 24 hours after dosing on day 80 and 90 | Measured in hours. |
| t½,sema; the terminal half-life of semaglutide | From 0 to 840 hours after dosing on day 90 | Measured in hours. |
Countries
Canada
Outcome results
None listed