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Gerinnungskrankheiten

Ort der Studie

Nederland (1)
Groningen

Geschlecht Beides
Alter von 18 bis 54
Gewicht in kg von 50 bis 150
Rauchgewohnheiten Nicht
BMI von 18 bis 29.9
Berechnen Sie Ihren BMI hier

Gerinnungskrankheiten

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

The research physician about this research

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

Important information about this study

The study already has 15 completed groups.
You will have plenty of free time during your stay at the research center to work or study.
After your first stay in the research center you can request an interim payment.

Note: for this clinical trial we are looking for healthy participants. You can therefore only participate in this study if you do not have any medical conditions. In addition, as a woman, you can only participate if you have a copper IUD, have gone through menopause or have been sterilized.

Group 1m	2 × 8 Tage Aufenthalt 10 Apr 2023 bis einschl. 17 Apr 2023 28 Apr 2023 bis einschl. 5 Mai 2023	Nachuntersuchung Nach Vereinbarung zwischen 26 Mai 2023 bis einschl. 2 Jun 2023	Anmerkung Also a follow-up by telephone on June 6, 2023	€ 3.949
Group 1n	2 × 8 Tage Aufenthalt 8 Mai 2023 bis einschl. 15 Mai 2023 26 Mai 2023 bis einschl. 2 Jun 2023	Nachuntersuchung Nach Vereinbarung zwischen 23 Jun 2023 bis einschl. 30 Jun 2023	Anmerkung Also a follow-up by telephone on July 4, 2023	€ 3.949

Who can participate?

You are a healthy male or female
You are between 18 and 54 years old.
Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 29.9 kg/m2.
Only non-smokers are allowed to participate in this study.

Note:

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.
To determine if you are eligible to participate in this study, you will undergo a medical screening.

As a female you are only allowed to participate in this study if you have not used hormonal contraception in the past year, you are not pregnant or breast-feeding and meet one of the following conditions:

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.
Females who are breastfeeding or pregnant cannot participate.

As a male you are only allowed to participate if you meet one of the following conditions:

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.

Compensation

You will receive a gross compensation of € 3590,- for full participation in the study.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 12 and a maximum of € 177 (840 kilometers) per round trip, irrespective of the method of transportation.

Period of stay

The study consists of multiple groups. You can only participate in one of the groups.

The study consists of 2 periods of 8 days (7 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 21 to 28 days after your last period of stay. A follow-up telephone call will take place 32 to 39 days after your last period of stay.
Before you can leave the research facility on the last day of (each) period, several final health checks will be performed. For some of the health checks the results are not immediately available, therefore there is a possibility that you can only leave the clinic in the afternoon. Also, there is a small chance that you will have to stay longer in the research center based on these results. If this happens, the compensation will be increased in proportion to the number of extra days.

If the dates change you will be notified as soon as possible.

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