Die Studie

Clinical trial of a new compound that has been developed for the treatment of bowel diseases.

  • You are a healthy male or female
  • You are between 18 and 65 years old
  • Your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2.
  • Both non-smokers and smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first administration in this clinical trial (counting from the last administration). This might be longer for certain trials, please contact us for more information.
  • 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 breastfeeding, and meet one of the following conditions:

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You are using a copper intra-uterine device;
  • You have passed the menopause (no period for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You abstain from (hetero)sexual intercourse (you are not sexually active) according to your lifestyle.

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

  • You are using a condom in combination with a contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause;
  • You abstain from (hetero)sexual intercourse (you are not sexually active) according to your lifestyle.

 

Zeitraum

  • The trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights), followed by 8 short visits including the follow-up.

PLEASE NOTE: You must be available for all dates to be able to participate in this study. 

 

Group 19  

9 Tage Aufenthalt

 
  • 2 Jan 2023 bis einschl. 10 Jan 2023
 

kurzer Besuch

 
  • 12 Jan 2023
  • 17 Jan 2023
  • 31 Jan 2023
  • 14 Feb 2023
  • 7 Mär 2023
  • 28 Mär 2023
  • 18 Apr 2023
 

Nachuntersuchung

 
  • 9 Mai 2023
 

 

Group 20  

9 Tage Aufenthalt

 
  • 16 Jan 2023 bis einschl. 24 Jan 2023
 

kurzer Besuch

 
  • 26 Jan 2023
  • 31 Jan 2023
  • 14 Feb 2023
  • 28 Feb 2023
  • 21 Mär 2023
  • 11 Apr 2023
  • 2 Mai 2023
 

Nachuntersuchung

 
  • 23 Mai 2023
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 4116 for participation in one of the groups.
  • 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.