In vivo Fasted state Bioequivalence study of Azithromycin 250 mg tablet in comparison to innovator product

Investigating in vivo bioequivalence of azithromycine 250 mg tablet

Twenty-four healthy male 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. In one period the test formulation and in another period the reference formulation (without knowing the formulation identity in each period). Therefore, each volunteer will be his own "Control".

After administration of one 250 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 (18-60) Exclusion criteria: Smoking, History of cardiovascular disease, liver and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy

Intervention group will receive one test drug product. Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector. Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.

Drug plasma concentration

A table of random numbers will be used. 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