Die Studie

  • You are a healthy male or female
  • You are between 18 and 55 years old.
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2. 
  • You do not smoke and did not use any nicotine-containing products in the past 6 months before admission.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening appointment (counting from the last dosing).
  • COVID-19 vaccines are allowed up to the day before your stay at our clinic.
  • Do you have a vaccination appointment planned, or have you recently been vaccinated and do you want to know whether you can participate in this study? Feel free to contact us to discuss the possibilities.
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) for at least 30 days prior to screening;
  • You are using a copper intra-uterine device for at least 30 days prior to screening;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active
  • You are only sexually active with a partner of the same sex

As a male you can only participate if you meet one of the following conditions:

  • Your female partner of childbearing potential is using a (copper) intra-uterine device or hormonal contraceptives for at least 30 days prior to your screening appointment.
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active;
  • You are only sexually active with a partner of the same sex.

Zeitraum

For the trial you will stay in the research facility in Groningen (location van Swietenlaan 6) for 27 days (26 nights). The follow-up visit will take place 2 to 6 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

 

Group 1  

27 Tage Aufenthalt

 
  • 30 Okt 2022 bis einschl. 25 Nov 2022
 

Nachuntersuchung

 
  • Nach Vereinbarung zwischen 27 Nov 2022 bis einschl. 1 Dez 2022
 

 

Group 2  

27 Tage Aufenthalt

 
  • 8 Nov 2022 bis einschl. 4 Dez 2022
 

Nachuntersuchung

 
  • Nach Vereinbarung zwischen 6 Dez 2022 bis einschl. 10 Dez 2022
 

 

Aufwandsentschädigung

  • You will receive a gross compensation of € 4302 for participation in this trial.
  • Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.