A Bioequivalence Study of Mirabegron 50 mg Prolonged-Release Tablets in Healthy Participants Under Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of mirabegron 50 mg prolonged-release tablets in healthy participants under fed conditions. Establishing bioequivalence is critical to ensuring that the test formulation provides the same rate and extent of absorption as the reference product, which is essential for maintaining predictable clinical performance.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female subjects. The participants belong to a vulnerable population and fall within age range 3. No specific medical conditions are reported for this cohort.

This Phase I bioequivalence study is designed as a randomized, double-blind, controlled trial to evaluate Mirabegron 50 mg prolonged-release tablets in healthy participants under fed conditions. The research methodology involves a specific sequence of study visits, beginning with a screening visit to assess eligibility. Following successful screening, participants will undergo subsequent follow-up visits and a final end-of-study visit. The total duration of participant involvement is determined by the clinical protocol, and early termination from the study may occur based on predefined clinical criteria or safety assessments. The estimated period for recruitment and study completion is from April 2026 to June 2026.

The provided source material does not contain information regarding the parameters, methods, or tools used to assess efficacy for this clinical trial.