In-vivo bioequivalence study of Resmetirom 100 mg tablet of the test drug manufactured by Actoverco pharmacutical company in compared with the reference drug Rezdiffra 100 mg tablet

In-vivo bioequivalence study of Resmetirom 100 mg tablet of the test drug manufactured by Actoverco pharmacutical company in compared with the reference drug Rezdiffra 100 mg tablet

Bioequivalence study, Cross-over design, Single dose, Single-blinded, 24 healthy volunteers, Two period, one week wash out period, Simple randomization method will be used.

This is a single-blind, two-period, crossover study conducted over two 120 hour periods with a one-week washout interval in two groups of healthy volunteers. The study will be conducted at the Clinical Unit of Tajzieh & Sanjesh Radin Shimi Company, located in Tabriz, Iran. In the first period, based on computer-generated randomization, the first group will receive the reference product and the second group will receive the test product. In the second period, the treatment sequence will be reversed. In this study, blinding is applied to the volunteers; therefore, none of the volunteers will be aware of whether they receive the test or reference product in any of the sampling periods.

Inclusion criteria: No history of cardiac, renal, and hepatic diseases; age between 18 and 55 years; body mass index within the range of 18–30. Exclusion criteria: Smoking; history of cardiovascular diseases; history of hepatic and renal diseases; addiction to alcohol and narcotic drugs; history of drug hypersensitivity; pregnancy.

Intervention group one receives Resmetirom 100 mg tablet of the test drug manufactured by Actoverco pharmacutical company in the first round, and in the second round, after one-week washout period, the drug Rezdiffra 100 mg tablet capsule. Intervention group No.2 receives the drugs in the switched order.

The concentration of the drug in blood, Time to reach maximum blood concentration, Extent of absorption

At first, all of the volunteers are evaluated for meeting inclusion criteria, selecting the final participants. Each volunteer is randomly assigned to a number between 1 and 24 using simple randomization, receiving an identification card containing the assigned number. Next, at first study period, volunteers with even numbers will receive the reference drug and volunteers with odd numbers will receive the test drug. In the second period, the formulations are switched in a cross-over design. The formulation assignment to the subjects is done randomly, with the participants and the trial staff not aware the formulation administered, thus, providing the blinding situation for all stages of the study.

This study is a single-blind (participant) clinical trial Resmetirom 100 mg tablet of the test drug manufactured by Actoverco pharmacutical company and the original brand are removed from their packaging by the operator and placed in identical, coded cans. Volunteers are unaware of the type of drug or test they are receiving.

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