In-vivo bioequivalence study of Sacubitril/Valsartan 100 mg tablet of the test drug manufactured by Mahban Darou pharmacutical company in compared with the reference drug Entresto 100 mg tablet

In-vivo bioequivalence study of Sacubitril/Valsartan 100 mg tablet of the test drug manufactured by Mahban Darou pharmacutical company in compared with the reference drug Entresto 100 mg tablet

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

This single-blind, two-period crossover study was conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 48hours, with a one-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 was single-blinded, meaning that participants were unaware whether they received the test or reference drug during either sampling period.

No history of heart, kidney & liver disease. 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 one receives Sacubitril/Valsartan 100 mg tablet of The Test Drug manufactured by Mahban daru pharmacutical Company in the first round, and in the second round, after a one-week washout period, the drug Entresto 100 mg tablet . Intervention group No.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. The formulation assignment to the subjects is done randomly, with the participants and the trial staff not aware the formulation administered, thus, providing the blinding situation for all stages of the study.

This study is a single-blind (participant) clinical trial Sacubitril/Valsartan 100 mg tablet of the test drug manufactured by Mahban daru 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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