A Randomized, Open-Label, Two-Period Crossover Bioequivalence Study Comparing Naproxen Sodium 660 mg Modified-Release Tablets to a Reference Modified-Release Product in Healthy Adults Under Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of naproxen sodium 660 mg modified release tablets compared to the reference product, Actromadol 660 mg modified-release tablets. This assessment is conducted in healthy adult male and female subjects under fed conditions to ensure that the test product demonstrates comparable pharmacokinetics to the reference product, which is essential for ensuring therapeutic equivalence in clinical application.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. This cohort includes vulnerable populations and falls within the age range designated by code 3. No specific medical conditions are reported for the subjects.

This steady-state bioequivalence study utilizes a randomized, 2-period, 2-sequence, crossover, open-label, and laboratory blinded design. The investigation compares Naproxen sodium 660 mg modified release tablets as the test product against Actromadol 660 mg modified-release tablets as the reference product. The study is conducted in healthy adult male and female subjects under fed conditions. The research methodology involves a sequence of study visits, beginning with a screening visit to assess eligibility. Following inclusion, subjects participate in specific study periods to evaluate the pharmacokinetic properties of the products. The protocol concludes with an end-of-study visit. Early termination from the study may occur based on predefined clinical criteria or safety considerations.

The provided source material does not contain information regarding the efficacy assessment parameters, methods, or tools for this clinical trial.