Single-dose bioequivalence studies of Valsartan tablets (160 mg) in healthy volunteers

Administration of generic and reference products to healthy subjects Comparison of bioavailability and pharmacokinetics of two products Evaluation of interchangeability of two products

26 healthy volunteers are divided into experimental and reference groups. For this purpose, first a total sample size of the candidates who met the inclusion criteria was determined and then 13 persons randomly assigned to the first group who use the test drug using the rand function of Excel software. And we assign another 13 people to the second group who receive the reference medicine. Then, in the second period, the group that received the test drug will receive the reference drug and the other group will receive the test drug. This clinical trial study with control group, double-blind, randomized, bioequivalence phase is performed on 26 patients.

This study was single-dose, randomized, and crossover. After completing the consent form and being aware of the drug and its side effects, the candidates consume the test product in one period and the reference product in the other period.

Inclusion criteria: Healthy volunteers aged 18 to 50 years Exclusion criteria: Age under 18 and over 50 and having any type of liver and kidney disease, etc.

Experimental Group: Receiving a single dose of 160 mg oral Valsartan products from Hakim company to determine bio-equivalence Control Group: Receiving a single dose of 160 mg oral Valsartan reference product to determine bio-equivalence

The variables of this study include the maximum plasma concentration of the drug, the time to reach the maximum plasma concentration of the drug and the area below the concentration versus time curve. The first two variables are a measure of drug uptake rate and the third variable is a measure of drug uptake.

In order to randomize, in this study, random allocation rule has been used. For this purpose, first a total sample size of the candidates who met the inclusion criteria was determined and then randomly assigned a number of 13 of them to the first group who use the test drug using the table of numbers. We assign the other 13 persons to the second group who receive the reference medicine. Then, in the second period, the group that received the test drug will receive the reference drug and the other group will receive the test drug

Candidates receive medication twice. Once Iranian product (generic) and once the foreign product (reference). The volunteers and the study physician do not know what product they received each time. Because the medicine is taken out of its box and blister and given to the volunteers, they will have no information about the type of medicine.