Learn more about this research?
- You are a non-, light or moderate smoker.
- You have a white skin
- Your Body Mass Index (BMI) is between 20 and 28 kg/m2 and your body weight is at least 50 kg. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 1.006,- for complete participation in one of the above groups.
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, irrespective of the method 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 (location UMCG) for 4 days (3 nights).
Please note: You have to be available for the entire period to participate in this study. These are the currently planned dates; however, these may be subject to change. If the dates do change you will be notified as soon as possible.
Information sheet PRA-189901
Type of study
The purpose of this study is to investigate how quickly and to what extent a new type of tablet from the approved compound is absorbed and eliminated from the body (this is called pharmacokinetics) when compared to a marketed tablet (this is called bioequivalence).
It will also be investigated how safe both tablets are when administered to healthy volunteers. The compound is not a new compound; both fomulations used in this medical-scientific research are already approved and available on the market.
The compound is already approved in many countries throughout the world, including Australia, Canada, the European Union, and the USA. The currently available pharmaceutical forms are prolonged release tablets for the treatment of chronic pain in adults, and immediate release tablets and an oral solution for the treatment of acute pain in adults.
In this study, two different prolonged release formulations will be compared. Both formulations are already approved and are available on the market.
The research will be performed in 40 healthy male volunteers. The research will be performed in 1 part.
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.
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 (location UMCG) for 4 days (3 nights).
Blood samples will be taken regularly during the study.
During the study, you will receive the known formulation (reference) as 1 tablet of 50 mg once and once 50 mg of the new formulation in 2 tablets (test).
You will receive the study compound after a standardized high-fat breakfast. This high-fat breakfast is an extensive breakfast with a fixed composition. The high-fat breakfast consists of:
• 2 fried eggs (in 15 g butter/margarine) (approximately 100 g)
• 1 portion of bacon (40 g)
• 1 portion of fried potatoes (115 g)
• 2 slices of (toasted) (wheat) bread with 15 g margarine
• 1 glass of high-fat milk (240 mL)
For vegetarians bacon may be replaced by brie 60+.
The breakfast has to be started exactly on time and has to be finished within 20 minutes. The entire breakfast must be consumed.
Risks and medical supervision
All drugs can potentially cause adverse reactions; the extent to which this occurs differs. The study compound(s) may also have side effects that are still unknown.
A great deal of knowledge has already been gained about the compound in humans from experience in numerous clinical studies in healthy volunteers and in patients. Single doses of up to 300 mg of the compound and doses of up to 250 mg of the compound twice daily with prolonged release of active substance were found to be safe and tolerable in healthy volunteers. The pharmaceutical formulations have already been approved and hence, the 50 mg dose of the compound per treatment period with prolonged release of active substance is considered safe for you.
The most common side effects (occurring in more than 10% of those treated) in medical scientific research on tablets with prolonged release of active substance in the dose range 50 mg to 250 mg twice a day were nausea, dizziness, sleepiness, headaches, and constipation.
You should be aware that possibly other, still unknown adverse effects may occur during the study. However, with the doses used in this study serious adverse effects are unlikely to occur.
You will be under strict medical supervision during the study.
Conditions for participation
You are a healthy male with a white skin between 18 and 55 years old and you do not smoke or are light or moderate smokers. Your Body Mass Index (BMI) is between 20 and 28 kg/m2 and your body weight is at least 50 kg. The BMI shows the relation between body weight in kilograms and height in meters.
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), some other juices and food, 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.
- Period of stay
- 8 days
- 0 times
- € 1.006,-
Group 1€ 1.006,-
8 days stay
- 27 May 2018 up to and including 30 May 2018
- 4 Jun 2018 up to and including 7 Jun 2018
Group 2€ 1.006,-
8 days stay
- 30 May 2018 up to and including 2 Jun 2018
- 7 Jun 2018 up to and including 10 Jun 2018
Group 3€ 1.006,-
8 days stay
- 24 Jun 2018 up to and including 27 Jun 2018
- 2 Jul 2018 up to and including 5 Jul 2018
Group 4€ 1.006,-
8 days stay
- 27 Jun 2018 up to and including 30 Jun 2018
- 5 Jul 2018 up to and including 8 Jul 2018
Group 5€ 1.006,-
8 days stay
- 8 Jul 2018 up to and including 11 Jul 2018
- 16 Jul 2018 up to and including 19 Jul 2018