A Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability of Naproxen Sodium 660 mg Modified-Release Tablets in Healthy Adult Subjects Under Fed Conditions

The primary objective of this study is to evaluate the relative bioavailability of a 660 mg naproxen sodium modified-release tablet compared to a 660 mg actromadol modified-release tablet in healthy adult subjects under fed conditions. This assessment is clinically significant for determining the equivalence of the test product to the reference product in terms of systemic exposure. The study design follows a crossover approach to facilitate the comparison of pharmacokinetic parameters between the two treatments. 8

The sponsor did not provide the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 30 years. Both male and female individuals are included, and the cohort contains vulnerable populations.

This Phase 2, single-dose, open-label, laboratory-blinded, randomized, crossover study is designed to assess the relative bioavailability of Naproxen sodium 660 mg modified release tablets compared to the reference product, Actromadol 660 mg modified-release tablets, in healthy adult male and female subjects under fed conditions. The methodology employs a 2-treatment, 2-period, 2-sequence design. The clinical investigation involves a screening visit to evaluate eligibility, followed by specific study periods to administer the respective treatments. The total duration of the study is estimated to occur between March 9, 2026, and March 31, 2026. Participation concludes with an end-of-study visit. Early termination from the study may occur based on predefined protocol criteria.

The provided source material contains no information regarding the assessment of efficacy, specific endpoints, or the methodology for evaluating clinical outcomes. Consequently, no parameters or measurement schedules can be described for this clinical trial.