Information on bioequivalence studies participation

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Medical Registrar of Clinical Trials Department

In order to become a participant in the study, you should fill in and submit an application form.

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You can withdraw the data you provided at any time and refuse to participate in the bioequivalence studies of drugs.

Information on research participation

General information

Dear candidate for participation in bioequivalence studies!

The National Anti-Doping Laboratory invites volunteers to participate in bioequivalence studies of drugs that will be conducted at out facility. The bioequivalence study is a comparative study of two drugs produced by different companies and having the same pharmaceutical substance. Studies are carried out only after program approval by the Ministry of Health of the Republic of Belarus and by the ethics committee. For participation in the study, the volunteer receives payment. Payment amount depends on the studied drug and duration of the study and is determined before the start of each study. Detailed information about the study and a description of the possible risks are provided to volunteers in advance. Only after reading and signing the informed consent document, the volunteer can take part in the study.

Basic study procedures


Before being included in the study, a volunteer will be screened at our facility. Studies can take place both at weekdays or weekends. A volunteer is hospitalized for 1-2 days (usually night-day-night). Volunteers are provided with food three times a day and stay under medical supervision. Food, medical examination, staying in the research center are free. During the study, a drug is usually taken once in a standard therapeutic dose (1 tablet). After that blood is drawn at regular intervals (18-25 times during the day). Blood loss is about 250 ml. A week later, the whole procedure is repeated. The total blood loss during the study is about 500 ml (for comparison, the standard blood loss for donation is 450 ml). A volunteer may refuse to participate in the study at any stage.

Preparation for laboratory tests (CBC, BIOCHEMISTRY OF BLOOD)

Basic requirements for preparing a volunteer / patient for blood giving (for blood test)


CBC

Preparation for the analysis :

  • Submit to a blood test in the morning on an empty stomach (or in the afternoon and evening hours, 4-5 hours after the last meal). Exclude foods high in fat from the diet 1-2 days before the study.
  • Between the last meal and taking blood should take from 8 to 12 hours. Drinking juice, tea, coffee is not allowed. Allowed to drink water.
  • The day before the test, avoid physical and thermal stress (bath, sauna, hot tub or shower), refrain from drinking alcohol and low alcohol drinks, do not smoke.
  • Before giving blood, it is necessary to exclude physical stress (running, fast climbing stairs), emotional arousal. It is recommended to relax, calm down 15 minutes before giving blood.
  • You should not giving blood for laboratory research immediately after physiotherapy procedures, instrumental examination, x-ray and ultrasound studies, massage and other medical procedures.
  • It is necessary to give blood before taking medications (consult a doctor if necessary).

Biochemistry of blood

Preparation for the analysis :

  • On an empty stomach, biochemical studies are performed on the content of glucose, creatinine, bilirubin in the blood, as well as the study of lipid profile parameters.
  • Between the last meal and taking blood should take from 8 to 12 hours. The use of juice, tea, coffee is not allowed. Allowed to drink water.
  • The day before the test, avoid physical and thermal stress (bath, sauna, hot tub or shower), without fail to refrain from drinking alcohol and low alcohol drinks, do not smoke.
  • Before blood giving, it is necessary to exclude physical stress (running, fast climbing stairs), emotional arousal. 15 minutes before blood donation, it is recommended to relax, calm down.
  • You should not giving blood for laboratory research immediately after physiotherapy procedures, instrumental examination, x-ray and ultrasound studies, massage and other medical procedures.
  • It is necessary to give blood before taking medications (consult a doctor if necessary).

Basic requirements for preparing a volunteer / patient for urine test

It is recommended to perform a urinalysis of the morning portion of urine.

The day before the collection of biomaterial, you should refuse products that can change the color of urine (for example, beets, carrots), exclude physical activity, alcohol, vitamins, dietary supplements, diuretics, spicy, salty food.

  • before passing the analysis, make a thorough toilet of the external genitalia;
  • women are advised to do the test before menstruation or 2 days after its completion;
  • collect the morning urine in a clean, dry plastic container with a lid (it is better to use special plastic disposable containers with screw caps);
  • for a correct urinalysis, a small amount of urine (the first 1 - 2 seconds of urination) is released into the toilet. Then, without interrupting urination, substitute a container for collecting urine urine and fill it in an amount of at least 20 ml of urine;
  • deliver urine with appointment card to urine examination to the laboratory (no later than 1.5 - 2 hours after collection). Long-term storage of urine leads to a change in its physical properties, the growth of bacteria and to the destruction of sediment elements.

Determination of narcotic drugs, psychotropic substances in human urine


FAQ


Who can become a study participant (volunteer)?

If you are over 18 and you are healthy, you may be a potential participant in the study as a volunteer.

You can not be a participant in the study if:

  • You have a chronic illness, an allergy to drugs, or severe food allergy;
  • You are constantly taking medicines;
  • You abuse alcohol, take narcotic drugs, actively smoke;
  • You are planning a pregnancy, are already pregnant, or breastfeeding.

What is the use of volunteer participation in the study?

For participation in the study, the volunteer receives payment. Payment amount depends on the studied drug and duration of the study and is determined before the start of each study.

During the study, you will be able to get more complete information about your health as a result of examinations and medical tests (complete blood count and urinalysis, blood test, electrocardiogram, screening for HIV, hepatitis B and C).

The study results will be useful for people receiving therapy with this drug.


Where will the study be conducted?

The study will be conducted at Clinical Trials Department of the National Anti-Doping Laboratory, which is located in the Republican Clinical Hospital for Disabled Great Patriotic War Veterans named after P.M.Masherov at the address: Minsk District, ag. Lesnoy, 5th floor of the medical building №2 (Borovlyany).


How long is participation in the study?

Duration of the study depends on the drug, the frequency of blood sampling and other reasons. Most often, a volunteer stays in the hospital for 1-2 days (usually night-day-night). In some cases, additional outpatient visits (without stay in a hospital) are possible. Studies can take place both at weekdays or weekends.


Can I participate in several studies?

You cannot participate in several studies at the same time. If you want, you can take part in the next study no earlier than 1-3 months after the end of previous study.


What are the health risks of participating in the study?

Prior to the study, a volunteer will get detailed information about the drug, its side effects and possible risks of the study. The drug is usually taken in a standard therapeutic dose. Information about possible risks and side effects is known, described in the medication package insert and provided in full to a volunteer before signing the informed consent. Prior to the start of the study, investigator will answer all your questions so you will be able to make an informed decision on participating in the study.

Every bioequivalence study is carried out only with the permission of the Ministry of Health of the Republic of Belarus and by the ethics committee.

During the study, you will be in a hospital under medical supervision.


Can I stop participating in the study after my agreement to participate in it?

You can stop your participation in the study at any time at your own request or for objective reasons beyond your control. The participation payment will be paid in proportion to your participation time in the study.


The National Anti-Doping Laboratory guarantees complete confidentiality of the received information. You can withdraw the data you provided at any time by your request.

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