Group A5b
- 27 Mai up to and including 5 Juni
Period(s) of stay (10 days)
- 27 Mai up to and including 5 Juni
- €2514,-
Compensation
- €2514,-
Follow up appointment between 26 jun en 28 jun 2024
Follow up
Follow up appointment between 26 jun en 28 jun 2024
Find out if you qualify for this trial
- 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 kg/m2
Good to know about this trial
- This is a medical trial with just 1 short stay
- The study compound will only be administered 1 time
- This medical trial does not have a busy schedule, you'll have a lot of free time
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
In this clinical trial we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy participants. We will also investigate how quickly and to what extent the study compound is absorbed, transported and eliminated by the body (this is called pharmacokinetics).
The study compound could potentially be used for the treatment of worsening heart failure. With worsening heart failure, the heart cannot pump the blood well enough anymore, resulting in blood and fluid collecting in the lungs and legs. Worsening of chronic heart failure is usually treated with diuretics, which are medicines that help reduce fluid buildup in the body, but do not fully resolve the congestion leaving the patients at risk of suffering new episodes of worsening heart failure and subsequent hospitalization. The study compound is aimed to relax the blood vessels, improve functioning of the heart and help the kidneys to remove water and salt.
Who can participate?
Target group
- You are a healthy male or female
- You are at least 18 and at most 65 years old.
- Your Body Mass Index (BMI) is greater or equal to 18.5 and less than or equal to 30.0 kg/m2.
- Both non-smokers and smokers (no more than 5 cigarettes or 1 cigar or 1 pipe per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from last follow up appointment from a previous clinical trial).
- To determine if you are suitable to participate in this trial, you will undergo a medical screening.
As a female you can only participate if you 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 periods for at least 12 months);
- You have been surgically sterilized at least 6 months prior to the first compound administration;
- Your male partner has been sterilized (i.e. vasectomized);
- You are not sexually active;
- You are only sexually active with a partner of the same sex.
As a male you can only participate if you meet one of the following conditions:
- You are using a condom in combination with an additional contraception method used by your female partner;
- You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
- You are not sexually active;
- You are only sexually active with a partner of the same sex.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Compensation
- You will receive a gross compensation of € 2514 for participation in this trial.
Travelling 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.
HOW LONG DOES THIS RESEARCH TAKE
Period of stay and research
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights). The follow-up visit will take place between 21 and 23 days after your departure from the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
Frequently asked questions
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Sie dürfen höchstens 4 Mal pro Jahr an einer Studie teilnehmen. Zwischen zwei Studien müssen mindestens 30 Tage liegen. Für einige Studien gilt eine längere Wartezeit.
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Während der Studie können leichte Beschwerden wie Kopfschmerzen oder Übelkeit auftreten. Dies kann durch das Medikament verursacht werden. Aber es kann zum Beispiel auch daran liegen, dass Sie für die Studie nüchtern bleiben müssen. Diese Nebenwirkungen sind unangenehm, aber glücklicherweise nicht gefährlich.
Bevor ein Medikament am Menschen erprobt werden darf, wurde es bereits umfassend in einem Labor getestet. So lässt sich gut vorhersagen, welche Nebenwirkungen eventuell bei Ihnen auftreten werden, damit Sie sich darauf einstellen können. So kommt es fast nie vor, dass Teilnehmer unter unerwarteten Nebenwirkungen leiden.
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Eine Studie umfasst in der Regel fünf bis zwölf Teilnehmer. Die Gruppen werden so zusammengestellt, dass sie optimal zu den Anforderungen der Studie passen. Diese Anforderungen sind in jeder Studie beschrieben. Sehen Sie sich alle aktuellen Studien an.