Die Studie

  • You are a healthy male or female
  • You are between 18 and 60 years old
  • You weigh a minimum of  50 kg and a maximum 110 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
  • You are not allowed to smoke 30 days before your pre-screening. Smoking is allowed during the medical trial, but smoking is not allowed during your stay in our research center.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to this clinical trial (counting from the follow-up visit). You also may not have participated in 4 or more studies in the 12 months prior to the first administration of this study.

  • 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 are using contraception (for example the contraceptive pill or an intrauterine device) in combination with a condom;
  • You have passed the menopause (no period for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You only have sexual contact with women.

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

  • You are using a condom and your female partner uses an effective contraceptive method (for example the contraceptive pill or an intrauterine device);
  • You have been sterilized or your female partner is sterilized or has passed the menopause;
  • You are not sexually active according to your lifestyle;
  • You only have sexual contact with men.

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 4 short visits. The 5th visit will be the follow-up visit and will take place around 2,5 months after your departure from the research facility.

NOTE: You must be available for all dates to be able to participate in this study. These are the currently planned dates; however, these may be subject to change

Aufwandsentschädigung

  • You will receive a gross compensation of € 3212 for full participation. 

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.