Die Studie

During the study we will compare 2 different formulations (tablet vs. solution) of the study drug. During 1 period you will receive a high-fat breakfast before administration of the study drug.

  • You are a healthy male or female.
  • You are between 18 and 60 years old. 
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
  • You do not smoke or use other nicotine-containing products.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial within 1 month prior to this clinical trial (counting from the last administration).
  • 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 meet one of the following conditions

  • You have passed the menopause (no menses for at least 12 months)
  • You have been sterilized.

As a male you can only participate if you are using a condom when you are sexually active, even when you have been sterilized or with a male partner.

Zeitraum

The trial consists of 3 periods during which you will stay in the research facility in Groningen for 4 days (3 nights) each. The follow-up visit will take place between 3 and 7 days after your departure from the research facility.

PLEASE NOTE: You must be available for all dates to be able to participate in this trial. The current dates of the trial will be published on our website. These are the currently planned dates; however, these may be subject to change.

Group 1  
stay  
  • 14 Oct 2021 up to and including 17 Oct 2021
  • 21 Oct 2021 up to and including 24 Oct 2021
  • 28 Oct 2021 up to and including 31 Oct 2021
 
follow-up by appointment
note Follow-up by appointment between 3 and 7 November
Group 2  
stay  
  • 19 Oct 2021 up to and including 22 Oct 2021
  • 26 Oct 2021 up to and including 29 Oct 2021
  • 2 Nov 2021 up to and including 5 Nov 2021
 
follow-up by appointment
note Follow-up by appointment between 8 and 12 November

Aufwandsentschädigung

  • You will receive a gross compensation of € 1905 for participation in one of the groups of this study.

    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.