Group 2
- 27 November up to and including 9 Dezember
Period(s) of stay (13 days)
- 27 November up to and including 9 Dezember
- 23 Dezember (phone call)
Follow-up
- 23 Dezember (phone call)
- €2970,-
Compensation
- €2970,-
Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
The study compound is a new compound that may potentially be used for the treatment of inherited metabolic diseases.
In this study we will investigate how quickly and to what extent the study compound is absorbed and eliminated from the body when administered as a capsule that you swallow compared to administration as a tablet that dissolves when placed on your tongue.
The study compound has been administered to 33 healthy volunteers before and is currently being used in the treatment of 11 patients.
The trial consists of two parts: group 1 and group 2. You can participate only in one of the two groups. In group 1 you will receive the study compound three times as a capsule or tablet. In group 2 you will receive the study compound two times as a tablet with and without breakfast.
Who can participate in this trial?
Note:
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
As a male you can only participate if you meet one of the following conditions:
WHO CAN PARTICIPATE?
You will receive a gross compensation of €2970 for participation in group 2.
Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of €13 and a maximum of €176,40 (840 kilometers) per round trip, regardless of the mode of transportation.
HOW LONG DOES THIS RESEARCH TAKE
Group 2:
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). There will be a follow-up phone call 13 to 15 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. The current dates of the clinical trial will be published on our website.
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
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.
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!
We pay the compensation for your participation, including travel expenses, within 21 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.