Fasted-state in vivo bioequivalence study of Calcium Dobesilate 500 mg Capsule manufactured by Abyan Pharmed compared with innovator product

In vivo fasted-state bioequivalence study of Calcium Dobesilate 500 mg capsule

The clinical trial has control and test groups with crossover, randomized design, without blinding. Twenty-four healthy male volunteers will participate randomly in the study as two twelve-person study groups. 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. 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 500 mg capsule to volunteer, the blood samples will be collected in predetermined time intervals up to 24 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 Tabriz University of Medical Sciences.

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

Intervention group will receive a single oral dose of test drug product (Calcium Dobesilate 500 mg capsule manufactured by Abyan Pharmed, Iran) and Control group will receive a single dose of reference drug product (Calcium Dobesilate 500 mg capsule manufactured in Canada). Blood samples will be taken for 24 hours 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.