A Randomized, Crossover Bioequivalence Study of Memantine 20 mg Capsules versus Memantine 20 mg Film-Coated Tablets in Healthy Volunteers under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of 20 mg memantine capsules compared to 20 mg film-coated tablets following a single oral dose administration under fasting conditions in healthy volunteers. Establishing equivalence between these dosage forms is clinically significant to ensure consistent systemic exposure for patients with Alzheimer’s disease. The 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 of both male and female genders. The participants fall within the age range category 3. The study involves individuals with Alzheimer’s disease.

This randomised, crossover, bioequivalence clinical trial is designed to compare the pharmacokinetic profiles of memantine 20 mg capsules and 20 mg film-coated tablets. The study involves a single oral dose administration conducted under fasting conditions in healthy volunteers. The research methodology follows a Phase I design to assess the equivalence of the two dosage forms. The sequence of procedures begins with a screening visit to determine eligibility. Following the administration of the study medication, participants will attend subsequent visits to monitor physiological parameters and collect biological samples for analysis. The protocol concludes with an end-of-study visit. Total participant involvement is determined by the specific dosing intervals and follow-up requirements. Study termination may occur if specific withdrawal criteria or safety protocols are met.

The assessment of efficacy in this Phase 2 clinical trial for Alzheimer’s disease is not specified.