A research study comparing the effect of different dosing conditions on blood levels of semaglutide in a new tablet composition in healthy participants
Key facts
- Where
- Neuss, NémetországSee the site
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Németország
- PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- EU 2023-503949-65-00
- Record updated
- 2023. december 12.
- Original description
To compare the effect of water volume and post-dose fasting period on the pharmacokinetics of semaglutide in healthy participants treated with oral semaglutide D for 10 daysRead full original descriptionShow less
Investigation of the effect of dosing conditions on the pharmacokinetics of new oral semaglutide formulation in healthy participants
To compare the effect of water volume and post-dose fasting period on the pharmacokinetics of semaglutide in healthy participants treated with oral semaglutide D for 10 days
Inclusion: Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive); 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.
Exclusion: Use of tobacco and nicotine products, defined as any of the below: 1. Smoking more than 5 cigarettes or the equivalent per day 2. Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods; History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant; Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator; Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the participant or reported in the medical records); HbA1c ≥ 6.5 % (48 mmol/mol) at screening.