Bioequivalence Study of Cladribine 10 mg Tablets Versus Mavenclad 10 mg Tablets in Healthy Adults Under Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of a single oral dose of Cladribine 10 mg tablets compared to Mavenclad® 10 mg tablets in healthy adult human subjects under fed conditions. Establishing bioequivalence is essential to ensure that the test product demonstrates a comparable rate and extent of absorption to the reference medicinal product. This study is categorized under scope 8.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers. The cohort is composed of males within the age group categorized by code 3. There is no specific therapeutic indication for this trial.

This Phase I, single-dose, open-label, bioequivalence study is designed to compare the pharmacokinetic profiles of 10 mg Cladribine tablets and the reference product, Mavenclad, in healthy adult subjects under fed conditions. The research methodology involves a comparative assessment of the test and reference formulations. The study sequence begins with a screening visit to confirm eligibility. Following inclusion, subjects will undergo the administration of the study medication and subsequent follow-up assessments to monitor physiological responses and drug absorption. The process concludes with an end-of-study visit. The total duration of participation is determined by the clinical protocol, and early termination may occur based on predefined safety or protocol deviation criteria.

The study involves healthy volunteers and does not have a therapeutic indication. Consequently, no efficacy parameters or clinical endpoints are assessed during this trial.