In vivo bioequivalence study of Azithromycin 500 mg tablet manufactured by Fatak shimin Co. in comparison to innovator product Zithromax®

Investigating In vivo bioequivalence of Azithromycin 500 mg tablet manufactured by Fatak shimi Co. in comparison to innovator product Zithromax®

Twenty-four healthy volunteer will enter the study based on random numbers table as two groups of twelve people. Each volunteer will receive a single dose of drug in two periods by cross-over design. In one phase the test formulation and in next phase the reference formulation (without knowing the formulation identity in each period). The groups will be assigned to test or reference drug randomly by lottery method. Therefore, each volunteer will be his own "Control".

After administration of one 500 mg tablet to volunteer, the blood samples will be taken in predetermined time intervals up to 72 hours. The samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. In this study the volunteer would not be aware of the formulation identity in each period

Inclusion criteria: General Health (Liver, Heart and Kidney), Age (20-60) Exclusion criteria: Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy

Test group: Administrating the test product and control group: Administrating the innovator product. In the first period, one group of volunteers will receive a single dose of Azithromycin 500 mg generic tablet (test formulation) and the second group will receive a single dose of the reference formulation of the same drug. After one week wash-out period, by cross-over design, the first group and second group will administer the reference and test formulations, respectively.

Drug plasma concentration

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. The selected individuals are placed in groups one and two. The lottery method is used to assign test drug or reference drug to groups.

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