Bioequivalence of Two Loperamide Formulations in Healthy Volunteers

The primary objective of this study is to evaluate the bioequivalence of two different formulations of loperamide. Establishing equivalence is clinically significant to ensure that alternative formulations provide the same systemic exposure and therapeutic effect as the reference product. The trial scope is 8.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female individuals. The cohort includes vulnerable populations. Age classification corresponds to code 3.

This study is a phase II, bioequivalence clinical trial designed to compare two formulations of loperamide. The research methodology involves a randomized, double-blind, controlled design conducted with healthy volunteers. The clinical sequence begins with a screening visit to evaluate eligibility. Subsequent study visits will be conducted to monitor the pharmacokinetic profile of the formulations. The process concludes with an end-of-study visit. The estimated duration for participant involvement is contained within the study period scheduled from May 2026 to June 2026. Early termination from the study may occur based on predefined clinical criteria.

The provided documentation does not contain information regarding the efficacy assessment, specific endpoints, or the methodology for evaluating the study objectives. Consequently, no parameters for measuring clinical outcomes, biomarker levels, or symptom improvement can be described.