A Bioequivalence Study Comparing Two Formulations of Rosuvastatin in Patients with Hypercholesterolemia

The primary objective of this study is to evaluate the bioequivalence of two different formulations of rosuvastatin in patients diagnosed with hypercholesterolemia. Establishing bioequivalence is clinically significant to ensure that the test formulation achieves similar pharmacokinetic properties and therapeutic outcomes as the reference product.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the specified age range, including both males and females. Participants are characterized by the absence of hypercholesterolemia.

This Phase II bioequivalence study is designed as a controlled clinical trial to compare two formulations of rosuvastatin in subjects with hypercholesterolemia. The research methodology involves a systematic sequence of study visits, beginning with a screening visit to assess eligibility. Following successful screening, participants undergo the experimental procedures, which are succeeded by follow-up visits and a final end-of-study visit. The total duration of participant involvement is determined by the established protocol, although certain conditions may necessitate early termination from the study. The estimated recruitment period for this trial is from March 2026 to April 2026.

The assessment of efficacy in this phase 2 clinical trial for hypercholesterolemia is not specified in the provided documentation.