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IRCT20231108059993N8 IRCT 2025-10-23 Arang Daroo Darman Comparative bioequivalence study of the Eltrombopag 50 mg Tablets, Manufactured by Daroo Darman Arang Pharmaceutical Company None Comparative bioequivalence Study of the Eltrombopag 50 mg Tablets, Manufactured by Arang Daroo Darman Pharmaceutical Company by Innovative Company (Revolade) 2025-11-05 anticipated 24 Complete https://irct.ir/trial/84976 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Individuals in the age group mentioned are invited to participate through an advertisement. Then, individuals are checked for health and healthy volunteers are identified. Each volunteer is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. Then, balls are randomly removed from the container. The first 12 people are considered as (sequence one: recipients of elentrombopag 50) and the second 12 people are considered as (sequence two: recipients of rovalipin 50). The participating volunteers are unaware of receiving the test drug or the brand drug, Blinding description: This study is a single-blind (participant) clinical trial. Eltrombopag tablets are removed from their packaging by the investigator and placed in identical, coded containers. Volunteers are unaware of the type of drug they are taking in each series of the experiment. Bioequivalence Healthy volunteer. Intervention 1: Intervention group 1 receives an Iranian drug and blood concentrations are obtained at specific time intervals. In the second series, this group receives the brand name drug. Intervention 2: The intervention group receives 2 brand drugs and blood concentrations are obtained at specific intervals. In the second series, this group receives the Iranian drug. Finally, the results obtained from the two intervention groups are compared and it is determined whether they are equivalent or not. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is None
public Saeed Ghanbarzadeh
No 10, Ave Mehrab, Ave Mirdamad
Tabriz Iran (Islamic Republic of) 5166934184 +98 41 3383 2649 s_ghanbarzadeh@yahoo.com Phayesh Daroo Zist Azma scientific Saeed Ghanbarzadeh
No 10, Mehrab, Ave, Mirdalad Ave
Tabriz Iran (Islamic Republic of) ۱۹۹۳۶۷۴۸۵۵ +98 21 8806 4460 s_ghanbarzadeh@yahoo.com Arang ِDaroo Darman Iran (Islamic Republic of) Must be in good general health (liver, heart, and kidneys). Body mass index should be in the range of 18-28. Informed consent must be obtained. Age must be between 18-60 years. 18 years 60 years Male History of allergic or adverse reaction to eltrombopag or any similar product. Addiction to cigarettes, alcohol, or any type of drug Volunteers with a history of chronic diseases such as high blood pressure or high blood lipids, etc. who have taken medication in the past two months. Other Other Intervention group 1 receives an Iranian drug and blood concentrations are obtained at specific time intervals. In the second series, this group receives the brand name drug. The intervention group receives 2 brand drugs and blood concentrations are obtained at specific intervals. In the second series, this group receives the Iranian drug. Finally, the results obtained from the two intervention groups are compared and it is determined whether they are equivalent or not. At specific intervals, the blood concentration of the drug is measured and compared in two series of blood draws, and it is determined whether the drugs are equivalent or not. Timepoint: Drug concentrations are measured at time intervals of 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after drug administration. Method of measurement: Liquid chromatography with dual mass spectrometer LC/MS/MS. Arang Daroo Darman Approved 2025-10-06 Ethics committee of ،Tabriz University of Medical Sciences Drug Applied Research Center, Tabriz University of Medical Sciences Daneshgah St. Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)