Clinical trial process

Your participation in the study will include several steps.

1) Call a Specialist Responsible for Subject Enrolment

Call +7 812 945-22-32 to schedule a screening visit (see information below).

2) Site Visit

You will be provided with detailed information about a future trial. If you meet trial requirements, you will be asked to sign an informed consent and undergo screening.

3) Informed Consent

During a discussion with the study doctor, a subject should learn about:

· The purpose of the study;

· Availability of study approval;

· Study duration;

· Blood sampling conditions;

· Conditions in which volunteers will find themselves during the study, information about food and water intake;

· Limitations in the use of medications during the study;

· Possibility to receive medical care during and after the study;

· Terms and conditions of insurance and compensation payment.

If a subject is added to the database, an individual file is created for them containing:

· Full name, age, address, telephone, passport data;

· Medical history (with chronic conditions and allergies);

· Previous illnesses for which the subject was hospitalised.

Before information is added to the database, subjects agree to the processing of their personal data. The site is responsible for maintaining confidentiality of volunteers and patients.

The individual file is used to record subject participation in all clinical trials of medicinal products.

Then, a subject volunteering for participation in the study should sign an informed consent form, a copy of which is given to the subject together with the study subject information leaflet.

4) Screening

Once the informed consent is signed, subjects will have a clinical and paraclinical assessments performed including a medical examination guided by the expected study drug effects and the following laboratory tests:

· Haematology;

· Urinalysis;

· Blood chemistry (standard tested parameters include total protein, bilirubin, creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, glucose, cholesterol, but may vary depending on the study);

· Blood tests for HIV, syphilis, hepatitis B and C viruses;

· ECG;

· Pregnancy test (for women only).

Assessment results are entered in case report forms. Based on the clinical examination and laboratory tests, the study doctor will decide whether or not the subject can be included in the bioequivalence study.

5) Study Procedures

Study procedures include a medical examination and, if necessary, clinical instrumental examinations (ECG, etc.) and laboratory tests (haematology, urinalysis, blood chemistry, pregnancy test for women), and drug administration.

During the trial, you will have multiple blood draws from the vein in your arm by a study nurse. The first blood sample will be taken pre-dose, and other samples collected according to the trial programme.

Trials usually require subject hospitalisation. The subject will need to stay at the clinic. The length of hospitalisation depends on the medication, number of doses, frequency of blood draws for testing, and other reasons.

6) Diet

During the trial, subjects receive good and well-balanced diet. As a rule, the menu consists of dietary meals excluding fatty and fried food and caffeinated beverages. The menu is made before the study and is brought to the site at a required time. The time by which the meal should be prepared, names of dishes, and number of servings are specified.

7) Leisure

Subjects have access to high-speed wireless internet connection (Wi-Fi), newspapers, and magazines.

8) Study Completion and Compensation

A compensation is usually paid to subjects 20 business days after completion of the trial. The payment is made to subject’s bank card. The amount of compensation is agreed prior to the trial.

Subjects completing the entire trial are paid 5, 000 to 45, 000 RUB. The amount of compensation depends on the drug, number of hours spent at the clinic, number of visits you need to make, number of blood draws, and several other factors.