In-vivo Bioequivalence Study of Lenvatinib 10 mg capsule of The Test Drug manufactured by Nano Fanavaran Darouei Alvand pharmaceutical company in Compared with The Reference Drug Lenvima 10 mg capsule

In-vivo Bioequivalence Study of Lenvatinib 10 mg capsule of The Test Drug manufactured by Nano Fanavaran Darouei Alvand pharmaceutical company in Compared with The Reference Drug Lenvima 10 mg capsule

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

This single-blind, two-period crossover study was conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 96hours, with a two-week washout interval between them. In the first period, based on computer-generated randomization, Group 1 received the reference drug while Group 2 received the test drug. In the second period, the treatments were switched. The study was single-blinded, meaning that participants were unaware whether they received the test or reference drug during either sampling period.

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 Lenvatinib 10 mg capsule of The Test Drug manufactured by Nano Fanavaran Darouei Alvand pharmaceutical company in the first round, and in the second round, after two-week washout period, the drug Lenvima 10 mg 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 Lenvatinib 10 mg capsule of The Test Drug manufactured by Nano Fanavaran Darouei Alvand pharmaceutical 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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