Die Studie

Study of an comparison between a tablet and capsule of a compound that is available for the treatment of leukemia.

  • Your Body Mass Index (BMI) is between 17.5 and 30.0 kg/m2 and your weight is at least 50 kg. The BMI reflects the relationship between your body weight in kilograms and your height in meters.
  • Both non-smokers and light smokers can participate, although smoking or use of other tobacco or nicotine containing products (e.g. nicotine gum) is not allowed 24 hours before and during your stay in our research center for each study period
  • You are only allowed to participate in this study if you did not participate in another drug study within 30 days prior to the first administration of the study compound (counting from the follow-up in the previous study).
  • As a female you are only allowed to participate if:
    - you have been surgically sterilized;
    - or you have been postmenopausal for at least 12 months.
  • As a male you are only allowed to participate if:
    - you will not donate sperm for at least 3 month after the last administration of study compound;
    - and you will use a condom and your fertile female partner will also use contraception (e.g. the pill or intrauterine device);
    - or you will be abstinent (not sexually active) in accordance with your lifestyle;
    - or you are only sexually active with a male and use a condom;
    - or your female partner is postmenopausal or sterile and you use a condom;
    - or you have been surgically sterilized and you use a condom.
  • To determine if you are eligible to participate in this study, you will first undergo a medical screening at our screening center in Groningen or Utrecht.

Zeitraum

The study consists of 2 periods of 6 days (5 nights) each in which you will stay in our research facility in Groningen. Each period will be followed by 1 short visit. After the second period you will be called 28 till 35 days after the last administration of the study compound for a phone follow-up call.

Please note: You can only participate in one group of this study. You also have to be available for all dates for the group of choice to be able to participate in this study. The dates of the study will be published on our website www.praclinicaltrials.com. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of € 2572 for full 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, irrespective of the method of transportation.