Fasted state in vivo bioequivalence study for Imatinib 100 mg capsule manufactured by Avicenna Co. in comparison to German brand AQVIDA

Investigating bioequivalence of Imatinib 100 mg capsule with innovator product manufactured in Germany

The present study is a randomized, single-blind, single-dose, 2-sequence, 2-period crossover trial. Twenty-four healthy volunteer will enter the study based on random numbers table as two groups of twelve people.

This study will be conducted on 24 healthy volunteers in Faculty of Pharmacy, Tabriz University of Medical Sciences. A table of random numbers will be used to assign the volunteers into two groups of study.

Inclusion criteria: General Health including Liver, Heart and Kidney health; being at the age of 20-60 years old. Non-inclusion criteria: Smoking; history of cardiovascular disease; history of liver and kidney disease; pregnancy; alcohol and drug addiction; history of drug allergy

Intervention group: In this group, a single dose of 100 mg imatinib capsule made by Avicenna company is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by AQVIDA Co. Germany is administered. Control group: In this group, a single dose of 100 mg imatinib capsule made by AQVIDA Co. Germany y is taken orally and then after a washout period of one week, a 100 mg imatinib capsule made by Avicenna company is administered.

Bio equivalence between two products based on FDA guidelines

A table of random numbers will be used. Random number tables are generated by computers that randomly set the numbers. First, a two-digit code (according to the number of volunteers, which is 24) is given to each candidate, and after creating the table, a random selection of numbers is made. To select sample people from the table, randomly start from a point in the table moving in the direction of the row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Moving in the direction of the row or column does not make any difference and this is optional. After this, the path numbers are controlled, which will be dealt with two types of numbers, one of which is smaller than the volume of the population of the study and the other is larger than the number of the population. Only smaller numbers should be considered and selected. The selected number is actually the individual code that is selected as the sample. This should be continued until enough small number can be selected based on the number of volunteers.

In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). This means that the product will be given to the volunteers for administration outside the original packaging