A Bioequivalence and Bioavailability Study of Indapamide SR 1.5 mg Mini-Tablets versus Indapamide SR 1.5 mg and Indapamide IR 2.5 mg Tablets in Healthy Participants Under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of one film-coated mini-tablet of indapamide SR 1.5 mg compared to one film-coated tablet of indapamide SR 1.5 mg. Additionally, the study aims to compare the bioavailability of one film-coated mini-tablet of indapamide SR 1.5 mg against one film-coated tablet of indapamide IR 2.5 mg in healthy participants under fasting conditions. 8

The sponsor did not provide the total number of participants for this study. The study population consists of healthy volunteers, including both male and female individuals. The participants belong to a specific age range categorized under code 3. The population includes vulnerable groups.

This Phase 2, bioequivalence study is designed to evaluate indapamide SR 1.5 mg in the form of one film-coated mini-tablet compared to one film-coated tablet of indapamide SR 1.5 mg under fasting conditions. Additionally, the trial aims to compare the bioavailability of the film-coated mini-tablet of indapamide SR 1.5 mg against one film-coated tablet of indapamide IR 2.5 mg. The research will be conducted in healthy participants. The study procedures involve a sequence of visits including a screening visit, subsequent dosing and observation periods, and an end-of-study visit. The total duration of the trial is estimated to occur between May 2026 and July 2026.

No information regarding efficacy assessment parameters, methods, or tools was provided in the source data.