In vivo fasted-state bioequivalence study of Sofosbuvir 400/Velpatasvir 100 tablet

In vivo fasted-state bioequivalence study of Sofosbuvir/Velpatasvir tablet

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 one Sofosbuvir 400/Velpatasvir 100 tablet, 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. 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. This study will be conducted without blinding.

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 product (Sofosbuvir/Velpatasvir of Bakhtar Bioshimi Co.) and Control group will receive a single dose of reference product (Sofosbuvir/Velpatasvir of Mylan Co., India). Blood samples will be taken for 72 hours at the mentioned time points 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.