A Randomized, Open-label, Two-period, Crossover Study to Compare the Relative Bioavailability of Naproxen Sodium 660 mg Modified-Release Tablets to a Reference Product in Healthy Volunteers under Fasting Conditions

The primary objective of this study is to assess the relative bioavailability of 660 mg naproxen sodium modified-release tablets compared to 660 mg actromadol modified-release tablets. This evaluation is clinically relevant for establishing the equivalence of the test product to the reference product under fasting conditions in healthy adult male and female subjects. 8

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both male and female individuals. The participants belong to an age range of 18 to 45 years. The trial is conducted under fasting conditions to assess bioavailability.

This Phase 1, 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 a reference product. The methodology utilizes a two-treatment, two-period, two-sequence design in healthy adult male and female subjects under fasting conditions. The study encompasses a recruitment period from January 14, 2026, to February 3, 2026.

The clinical trial evaluates bioavailability in healthy volunteers. Assessment is conducted under fasting conditions.