Hereditary swelling
- Geschlecht Beides
- Alter von 18 bis 60
- Rauchgewohnheiten Nicht
- BMI von 18 bis 30
- Berechnen Sie Ihren BMI hier
Study of a new compound that is being developed for the treatment of hereditary swelling (body fluid accumulation) of skin or tissue.
Particulars
- You are a healthy male or female between 18 and 60 years old
- You do not smoke, or quit at least 1 month before the start of the study.
- Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 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 within 30 days preceding the first administration of this study compound, counting from the last day in the previous study.
- As a male you are only allowed to participate in this study if:
- your female partner uses a hormonal contraceptive (e.g. the pill or intrauterine device) in combination with a diaphragm, cervical cap or condom;
- or a condom if your partner is pregnant;
- or you were 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 completely abstinent (not sexually active) in accordance with your lifestyle;
- As a female you are only allowed to participate in this study if:
- or you were surgically sterilized at least 6 months before the start of the study;
- or you have been postmenopausal for at least 12 months.
- 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.
Compensation
You will receive a gross compensation of € 1522 for full participation in one of the groups.
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.
Period of stay and research
The study consists of 1 period where you will stay for 10 days (9 nights) in our research facility in Groningen.
After this period of stay you will have to return once for your follow-up visit.
This will take place between 5 - 9 days after leaving our research centre:
Group 1: between 30 March and 3 April 2020.
Group 2: between 06 April and 10 April 2020,
Group 2 |
10 days stay
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Follow-up
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