In vivo Bioequivalence study of Hydrochlorothiazide 25 mg tablet manufactured by AaniDarman Pharmaceutical Co. Compared to innovator Product

In vivo fasted-state bioequivalence study of Hydrochlorothiazide 25 mg tablet

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. . 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 one 25 mg tablet to volunteer, the blood samples will be collected in predetermined time intervals up to 48 hours. The samples will be stored in freezer -4 degrees centigrade until analysis. The concentration of drug in blood samples will be measured by liquid chromatography. The study will be performed in 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 are healthy volunteers that will receive a single oral dose of test product (Hydrochlorothiazide tablet manufactured by AaniDarman, Iran) in the first phase of the study and Control group are also healthy volunteers that will receive a single dose of reference product (Hydrochlorothiazide tablet manufactured by Bayer, Germany) in the first phase of the study. Since the design of the study is cross-over, in the second series of drug administration, the intervention and control groups are switched. Blood samples will be taken for 48 hours and the plasma will be stored in freezer until analysis.

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.