In-vivo bioequivalence study of Esomeprazole 20 mg – Naproxen 500 mg tablet of the test drug manufactured by Actoverco pharmacutical company in compared with the reference drug Vimovo 20-500 mg tablet

In-vivo bioequivalence study of Esomeprazole 20 mg – Naproxen 500 mg tablet manufactured by Actoverco pharmacutical company in compared with the reference drug Vimovo 20-500 mg tablet

Bioequivalence study, Cross-over design, Single dose, Single-blinded, 24 healthy volunteers, Two period, two week wash out period, Simple randomization method will be used.

This single-blind, two-period crossover study is conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 72 hours, with a two -week washout interval between them. In the first period, based on computer-generated randomization, Group 1 received the reference drug while Group 2 received the test drug. In the second period, the treatments were switched. The study is single-blind in which participants are unaware whether they receive the test or reference drug during either sampling period.

Inclusion criteria: the ages and BMIs of participant should be in the range of 18-55 and 18-30 respectively. Exclusion criteria: Smoking, Alcohol and drug addiction, History of allergy to drug, Pregnancy.

Intervention group 1 receives Esomeprazole 20 mg–Naproxen 500 mg tablet of the test drug manufactured by Actoverco pharmacutical company in the first round, and in the second round, after two-week washout period, the drug Vimovo 20-500 mg tablet . Intervention group 2 receives the drugs in the switched order.

The concentration of the drug in blood, Time to reach maximum blood concentration, Extent of absorption

At first, all of the volunteers are evaluated for meeting inclusion criteria, selecting the final participants. Each volunteer is randomly assigned to a number between 1 and 24 using simple randomization, receiving an identification card containing the assigned number. Next, at first study period, volunteers with even numbers will receive the reference drug and volunteers with odd numbers will receive the test drug. In the second period, the formulations are switched in a cross-over design.

This study is a single-blind (participant) clinical trialEsomeprazole 20 mg – Naproxen 500 mg tablet of the test drug manufactured by Actoverco pharmacutical company and the original brand are removed from their packaging by the operator and placed in identical, coded cans. Volunteers are unaware of the type of drug or test they are receiving.

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