Comparative Bioequivalence Study of the Eltrombopag 50 mg Tablet Manufactured by Actero Middle East Pharmaceutical Company by Innovative Company

Comparative Bioequivalence Study of the Eltrombopag 50 mg Tablet Manufactured by Actero Middle East Pharmaceutical Company by Innovative Company

This is a double-blind, randomized, crossover clinical trial. (Using the rand function of Excel software). The bioequivalence phase will be conducted on 24 healthy volunteers. In this study, there are two intervention groups, each with 12 volunteers. The first group will take the Iranian drug and the second group will take the brand drug. After a 2-week washout period, the first group will take the brand drug and the second group will take the Iranian drug. Each person is their own control sample, and the results of each person in each round of the experiment will be compared with their own results in the second round of the experiment.

Volunteers from the city of Tabriz were randomly selected and after ensuring their health, the volunteers were randomly and double-blindly divided into two intervention groups. The first group will receive the Iranian drug and the second group will receive the brand drug. After 2 weeks, the first and second groups will receive the brand or Iranian drug, respectively, in a crossover manner. In such a way that no one except the experimenter will know the type of drug they will take.

General health (liver, heart and kidneys). Body mass index (18-28). Informed consent. Volunteers age (18-60 years). Sensitivity to Company

Volunteers will be randomly divided into two intervention groups and will take one Eltrombopag 50 mg Tablet of Iranian-made and brand, respectively. According to the protocol, blood will be drawn at different times (16 points), and after a 2-week washout period, they will take the branded and Iranian drug in a cross-over manner.

ِِDrug Plasma Concentration

In order to randomly assign individuals to two groups, 24 cards numbered 1 to 24 in sealed envelopes placed in random order will be used. Each volunteer will pick an envelope after entering the study, and those who picked numbers 1-12 will be placed in group A and those who picked numbers 13-24 will be placed in group B. Volunteers in group A will receive the Iranian drug and volunteers in group B will receive the brand drug, and blood will be drawn at specific intervals according to a specific protocol. After a 2-week cleansing period, cross-over, those who have taken the Iranian drug will take the Brand drug and those who have taken the foreign drug will take the Iranian drug, and blood will be drawn again at different intervals. The blood draw results of each person in the second series of blood draws will be compared with their own blood draw results in the first round.

This study is a double-blind clinical trial. Eltrombopag 50 mg tablets are removed from their packaging by the investigator and placed in identical, coded containers. Except for the principal investigator, neither the patient, the physician, nor other medical personnel, nor even those performing the concentration analysis, know which patient took which drug in the first or second round