Safety and Tolerability Assessment of a Medicated Chewing Gum Containing Sodium Alginate, Calcium Carbonate, and Sodium Bicarbonate in Healthy Volunteers

The primary objective is to evaluate the safety and tolerability of a medicated chewing gum formulation containing sodium alginate, calcium carbonate, and sodium bicarbonate. Assessment of these parameters is essential to determine the physiological impact and acceptable administration of the product.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. The participants belong to a vulnerable population and fall within the age range categorized by code 3.

This Phase 3 clinical trial is designed to evaluate the safety and tolerability of a medicated chewing gum containing sodium alginate, calcium carbonate, and sodium bicarbonate. The study follows a controlled methodology to assess the investigated product. The research process includes a screening visit to determine eligibility, followed by scheduled study visits and an end-of-study visit. The total duration of the trial is estimated to occur between February 18, 2026, and March 23, 2026. Participant involvement may be subject to early termination based on specific clinical criteria.

No information regarding the assessment of efficacy is provided in the source material.