- You must speak and understand English or Dutch to participate. This study takes place in The Netherlands.
- You do not smoke.
- Your Body Mass Index (BMI) is between 18 and 29.9 kg/m2 and your body weight is between 50 and 120 kg. The BMI shows the relation between body weight in kilograms and height in meters.
- Females are only allowed to participate in this study if they are surgically sterilized for at least 6 weeks (Essure® methods is not allowed for this study or are postmenopausal for at least 12 months (without menstrual periods).
- To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
You will receive a gross compensation of € 1.738,- for participation in one of the groups of this study.
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 return, regardless of the mode of transportation.
Period of stay and research
The study consists of 2 periods. For each period, you will stay in our research facility in Groningen in The Netherlands for 6 days (5 nights).
The follow-up is the day of departure. Approximately 30 - 35 days after the last administration of the study compound, you will be contacted by phone and asked about your health status. The appointment for this follow-up phone call will be made during the study.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 60 days between follow up in the previous study to dosing in this study.
The medical screening for this study will take place in the screening center in Groningen or Utrecht in The Netherlands.
Type of study
This study will be performed in 98 healthy male/female volunteers. A total of 24 volunteers will be enrolled in Group 1 and 74 volunteers in Group 2.
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of the compound are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated whether these characteristics are the same for both batches (this is also called bioequivalence).
In addition, the effect of food on the pharmacokinetics of both batches will be investigated. It will also be investigated to what extent the compound is tolerated.
The study will only take place after it has been approved by the Independent Ethics Committee
Setup and duration of the study
To determine if you are suitable to participate in this study, you will undergo a medical screening visit at the centre in Groningen.
Following the screening visit, if you are eligible for participation, the study consists of 2 periods. For each period, you will stay in our research facility in Groningen for 6 days (5 nights).
Blood samples will be taken regularly during the study.
Risks and medical supervision
Each participant will receive once the compound of one batch and once the compound of the other batch. The order in which you receive these formulations will be determined by chance; we call this randomized. The participants will also be randomized in 2 groups:
- Group 1 receives the study compound with a high-fat breakfast
- Group 2 receives the study compound in fasted condition
The new investigational compound may cause side effects.
In the 2 healthy volunteers studies where the compound was administered at a single dose of 400 mg or 300 mg, the very common adverse events (occurring in 10% or more of subjects) reported were inflammation of the urethra, nausea and common cold. Common adverse events occurring in more than or equal to 1% and less than 10% of subjects were oral herpes and toothache. You will be under strict medical supervision during the study.
Conditions for Participation
You are a healthy male or female between 18 and 55 years old. You can only take part in the study if you do not smoke.
Females are only allowed to participate in this study if they are surgically sterilized for at least 6 weeks (Essure® methods is not allowed for this study) or if they are postmenopausal for at least 12 months (without menstrual periods).
The study will be done under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study are not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened.
Sign up for one of the following study groups
2× 6 days stay
- 20 Jan 2019 up to and including 25 Jan 2019
- 4 Feb 2019 up to and including 9 Feb 2019
2× 6 days stay
- 23 Jan 2019 up to and including 28 Jan 2019
- 7 Feb 2019 up to and including 12 Feb 2019
2× 6 days stay
- 27 Jan 2019 up to and including 1 Feb 2019
- 11 Feb 2019 up to and including 16 Feb 2019
2× 6 days stay
- 30 Jan 2019 up to and including 4 Feb 2019
- 14 Feb 2019 up to and including 19 Feb 2019