In vivo fasted-state bioequivalence study of Primidone 125 mg/5ml suspension manufactured by Ashbal shimi Pharmaceutical Co. compared to innovator product

In vivo fasted-state bioequivalence study of Primidone suspension

The clinical trial has control and test groups with crossover, randomized design, without blinding. 24 healthy male volunteers will participate randomly in the study as two twelve-person groups. Each volunteer will receive a single dose in two periods. In one period the test and in another period the reference formulation. Therefore, each volunteer will be his own "Control". To randomly assign participants in two groups, the lottery method will be used.

After oral administration of 2.5 ml Primidone suspension to volunteer, the blood samples will be collected in predetermined time intervals up to 72 hours. The samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. The concentration of drug in blood samples will be measured by liquid chromatography equipped with mass spectroscopy detector. The study will be performed in Faculty of Pharmacy, Tabriz University of Medical Sciences.

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney diseases), Age (18-59 years old) Exclusion criteria: Smoking, History of cardiovascular disease, liver and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy

Intervention group will receive a 2.5 ml of test drug product (Primidone suspension manufactured by Ashbal Shimi, Iran) and Control group will receive 2.5 ml of reference drug product (Primidone suspension manufactured in Germany). Blood samples will be taken from the volunteers for 72 hours at the mentioned time points after drug administration and the plasma will be stored in freezer until analysis. In both groups, breakfast and lunch will be served two and six hours after drug administration, respectively).

Drug plasma concentration

To randomly assign participants in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope. Numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of both groups will change for the second period.