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- Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body
weight in kilograms and length in meters.
- Both non-smokers and moderate smokers are allowed to participate in this study; however, from 48 hours
before and during your stay in the research facility, smoking is not allowed.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.436,- for participation in one of the groups of Part A of this study. For participation in Part B you will receive a gross compensation of € 1.264,-.
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
For group 1 and 2 (Part A) the study consists of 4 periods. During each period you will stay in our research facility in Groningen (location UMCG) for 5 days (4 nights).
For group 3 (Part B) the study consists of 2 periods. During each period you will stay in our research facility in
Groningen (location UMCG) for 5 days (4 nights).
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.
Information sheet PRA-164791
Type of study
The purpose of the study is to investigate how quickly and to what extent the drug to be investigated (hereafter: the drug) is absorbed and eliminated from the body in comparison to a similar drug and in relation to the results of the earlier studies performed with these compounds. In addition, the safety and tolerability of the drug and the similar drug on several markers related to blood clotting will be investigated. The drug is no new drug; it is already available in the market since 1992. The similar drug is also available in the market under several dosages.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The study consists of two parts: Part A (Groups 1 and 2) and Part B (Group 3).
For Part A the study will consist of 4 periods during which you will stay in the clinical research center in Groningen (location UMCG) for 5 days (4 nights). The drug will be given once in 3 periods, with a different dose in every period. The similar drug will be given once in 1 period. Both drugs will be given as an intravenous injection and the sequence of the administration of the drugs and the doses will be determined by chance.
For Part B the study will consist of 2 periods during which you will stay in the clinical research center in Groningen (location UMCG) for 5 days (4 nights). The drug will be given in 1 period and the similar drug will be given in 1 period. Both drugs will be given as an intravenous injection and the sequence of the administration of the drugs will be determined by chance.
Blood samples will be taken regularly during both parts of the study.
Risks and medical supervision
The drug is a medicine that prevents blood from clotting and to treat blood clots in blood vessels. It belongs to a group of medicines called heparinoids. The drug blocks a step in the coagulation cascade, a series of reactions in your body which result in the formation of blood clots. The drug is no new drug; it is already available in the market since 1992. Over time, the production process was adapted several times resulting in the question whether the compound still has the same availability and effect in the body. The similar drug is also being used for the prevention and treatment of thrombosis and used as a comparator in this study.
All drugs cause adverse effects; however not everybody will get them and the extent to which this occurs differs. Both compounds you will receive in this study have been used for over 20 years.
The most frequently observed adverse effects of the drugs are: a large drop in the number of cells that clot the blood (thrombocytopenia) in patients already hypersensitive to heparin, skin rash, increased bleeding after surgery, bruises and/or pain around the injection site, allergic reactions and itching.
The most frequently observed adverse effects of the similar drug are: bleeding, changes in your blood (too few or too many cells that clot the blood), allergic reactions, a rash of dark red spots under the skin which do not go away when you put pressure on them, itch, rash, pain in the area you have been injected in, hematoma under the skin showing as red dots or purple patches on your skin and other reactions in the injection area, such as pain, swelling, irritation or inflammation.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male between 18 and 30 years old. You can only participate in the study if you do not smoke or are a light to moderate smoker, however, smoking is not allowed from 48 hours before and during your stay in the research center.
The study will be executed 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 is 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; this screening will take place within 3 weeks before the start of the study
- Period of stay
- 10 until 20 days
- 0 times
- € 1.264,- until € 2.436,-
Group 1€ 2.436,-
20 days stay
- 1 Nov 2017 up to and including 5 Nov 2017
- 8 Nov 2017 up to and including 12 Nov 2017
- 16 Nov 2017 up to and including 20 Nov 2017
- 23 Nov 2017 up to and including 27 Nov 2017
Group 2€ 2.436,-
20 days stay
- 5 Nov 2017 up to and including 9 Nov 2017
- 12 Nov 2017 up to and including 16 Nov 2017
- 19 Nov 2017 up to and including 23 Nov 2017
- 27 Nov 2017 up to and including 1 Dec 2017
Group 3€ 1.264,-
10 days stay
- 8 Feb 2018 up to and including 12 Feb 2018
- 15 Feb 2018 up to and including 19 Feb 2018