A Bioequivalence Study of Mirabegron 50 mg Extended Release (ER) Tablet: Comparison of the Test Drug Manufactured by Actoverco Pharmaceutical Company with the Reference Drug, Betmiga 50 mg

A Bioequivalence (BE) study of Mirabeta (Mirabegron) 50 mg Extended Release (ER) tablet manufactured by Actoverco Pharmaceutical Company in comparison with the reference drug Betmiga 50 mg Extended Release (ER) tablet.

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

This single-blind, cross-over trial is conducted in two 144-hour periods with a five-week Washout Period (WP) on healthy volunteers at Radin Shimi Company, Tabriz. In the first period, based on computer randomization, one group receives the reference drug and the other receives the test drug; in the second period, this sequence is reversed. Participants are blinded, meaning they remain unaware of whether they receive the test or reference drug during any sampling period.

Inclusion Criteria: No history of cardiac, renal, or hepatic diseases; age between 18 and 55 years; body mass index between 18 and 30. Exclusion Criteria: Smoking; alcohol or substance abuse; history of drug hypersensitivity; pregnancy.

Participants in this study are divided into two groups; such that Intervention Group 1 receives a single dose of Mirabeta (Mirabegron) 50 mg Extended Release (ER) tablet manufactured by Actoverco Pharmaceutical Company in the first period, and after a five-week Washout Period (WP), receives the reference drug Betmiga 50 mg Extended Release (ER) tablet manufactured by Astellas Pharma in the second period, while Intervention Group 2 receives these medications in the reverse order.

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

First, all candidates are screened based on the inclusion criteria and selected. Each participant is randomly assigned a number between 1 and 24 using Microsoft Excel software. Then, each participant receives an identification card containing the assigned number. In the first phase, participants with even numbers will receive the reference drug, and participants with odd numbers will receive the test drug. In the second phase, the drugs are crossed over. The sequence of drug allocation to the numbers is performed randomly and without the knowledge of the participants and the evaluation team; thus, the blinding of the participants and investigators is maintained at all stages of the study.

This study is a single-blind (participant) clinical trial. Mirabegron 50 mg ER tablet of The Test Drug manufactured by Actoverco pharmaceutical 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.

These data are as secure between researchers and related industries.