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Clotting disorders

Geschlecht Beides

Alter von 18 bis 54

Gewicht von 50 bis 100

Rauchgewohnheiten Nicht

BMI von 18 bis 29.9

Berechnen Sie Ihren BMI hier

Ort der Studie

Study of a new compound that is being developed for the treatment of blood clotting disorders

 

Besonderheiten (auf Englisch)

  • You are a healthy male or female between 18 and 54 years old.
  • Only non-smokers are allowed to participate in this study.
  • Your weight is between 50 and 100 kg and your Body Mass Index (BMI) is between 18.0 and 29.9 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • You have not participated in any other drug study (counting from the last drug administration) within 1 month preceding the first administration of this study. For specific studies this could be 3 months.
  • As a male you are only allowed to participate in this study if:
    • You use a condom;
    • or you have been vasectomized at least 6 months before the start of the study;
    • or your female partner is postmenopausal (at least 12 months without menstruation) or surgically sterilized (at least 6 months);
    • or you are only sexually active with a male;
    • or you are fully abstinent (not sexually active) in accordance with your lifestyle.
  • As a female you are only allowed to participate in this study if:
  • you do not use hormonal contraception and have not used it in the last year
    • you use a copper intrauterine device;
    • or you are postmenopausal (at least 12 months without menstruation);
    • or you were surgically sterilized at least 6 months before the start of the study, or your partner is sterilized;
    • or you are only sexually active with a female;
    • or you are fully abstinent (not sexually active) in accordance with your lifestyle.
  • Women who are breastfeeding or pregnant cannot participate.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Vergütung (auf Englisch)

You will receive a gross compensation of € 2.664,- for full participation in group 1a, 1b, 1c or 1d and a gross compensation of € 2.003,- for full participation in group 2a, 2b, 2c or 2d. 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.

 

Periode und Studie (auf Englisch)

The study consists of 2 parts: 1 and 2. You can only participate in one of the groups of part 1 or 2.

Group 1a, 1b1c or 1d consists of 3 periods of 5 days (4 nights) each in our research facility in Groningen. After the last period of stay you will have to return once for your follow-up visit, which will take place 10 – 14 days after your last period of stay.
Group 2a, 2b, 2c or 2d consists of 1 period of 13 days (12 nights) in our research facility in Groningen. After this period of stay you will have to return once for your follow-up visit, which will take place 3 – 5 days after your last stay. 

 

Group 2h

13 days stay

22 Nov 2020 up to and including 4 Dec 2020

note

Follow-up by appointment between 07 - 09 December 2020.

Group 2i

13 days stay

30 Nov 2020 up to and including 12 Dec 2020

note

Follow-up by appointment between 15 - 17 December 2020.

 

Group 2j

13 days stay

6 Dec 2020 up to and including 18 Dec 2020

note

Follow-up by appointment between 21 - 23 December 2020.

Group 2k

13 days stay

12 Dec 2020 up to and including 24 Dec 2020

note

Follow-up by appointment between 27 - 29 December 2020.

Group 2l

13 days stay

5 Jan 2021 up to and including 17 Jan 2021

note

Follow-up by appointment between 20 - 22 January 2021

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