Group 1 - male onl
- Only males
- 16 up to and including 29 April
Period(s) of stay (14 days)
- 16 up to and including 29 April
- 3 May (phone call)
Follow-up
- 3 May (phone call)
- €3187,-
Compensation
- €3187,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 55 years old
- You weigh more than 50 kg
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2
Good to know about this trial
- The study compound has been administered to humans before.
- The study compound is administered as tablets for swallowing.
- You receive the compound once daily for 10 days.
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants. The effects of the study compound are compared with the effects of a placebo (compound without active substance). Whether you receive the study compound or placebo is determined by chance.
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
Who can participate?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 55 years old.
- Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2 (inclusive).
- Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). 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 the follow-up visit of the previous 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 are not pregnant, not breast feeding and meet one of the following conditions:
- You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
- You are using a copper intra-uterine device in combination with a condom;
- You have passed the menopause (no periods 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 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 according to your lifestyle;
- 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 € 3187 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 14 days (13 nights). The follow-up visit will take place on the day of your departure from the research facility. 4 to 6 days after your departure from the research facility, you will be contacted by phone for some questions.
Note: You must be available for all dates to be able to participate in this clinical trial.
Frequently asked questions
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You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.
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During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
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Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!