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

The primary objective of this study is to evaluate the bioequivalence of 50 mg mirabegron prolonged-release tablets following multiple-dose administration in healthy participants under fasting conditions. Establishing bioequivalence is essential to ensure that the therapeutic profile and pharmacokinetics of the formulation remain consistent with established standards.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. This cohort encompasses vulnerable populations within the 3-17 age range. No specific medical conditions are reported for the subjects.

This Phase 1, bioequivalence study is designed as a randomized, double-blind, controlled trial to evaluate the pharmacokinetics of Mirabegron 50 mg prolonged-release tablets in healthy participants under fasting conditions. The research methodology involves a sequence of scheduled study visits, beginning with a screening visit to assess eligibility. Subsequent visits include periodic assessments to monitor the drug's profile, concluding with an end-of-study visit. The estimated duration of the study period is approximately one month. Participants may undergo early termination of involvement if specific pre-defined clinical criteria or safety protocols are met.

No efficacy parameters, assessment methods, or clinical endpoints are specified for this study.