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

The primary objective of this study is to evaluate the bioequivalence of mirabegron 50 mg prolonged-release tablets in healthy participants under fasting conditions. This assessment is clinically significant to ensure that the test product demonstrates comparable pharmacokinetics to the reference product. No secondary objectives were identified.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The cohort includes vulnerable populations and individuals within the age range of 18 to 45 years. No medical conditions are reported for this group.

This study is a Phase 1, bioequivalence trial designed to evaluate the performance of Mirabegron 50 mg prolonged-release tablets in healthy participants under fasting conditions. The research methodology employs a randomized, double-blind, controlled design. The study sequence begins with a screening visit to assess eligibility. Subsequent study visits are conducted to monitor physiological responses and pharmacokinetic parameters. The process concludes with an end-of-study visit. The total duration of participant involvement is determined by the protocol-defined visit schedule. Early termination from the study may occur based on predefined clinical criteria or safety concerns.

No information regarding efficacy assessment parameters, measurement methods, or specific clinical tools is provided in the source data.