An Open-Label Palatability Study of a Novel Orodispersible Paracetamol and Ibuprofen Formulation Following Single Oral Administration in Healthy Volunteers

The primary objective of this study is to evaluate the palatability of a novel orodispersible formulation containing a combination of paracetamol and ibuprofen following a single oral administration in healthy volunteers. This assessment is clinically relevant to ensure patient compliance and ease of administration for oral medication. There are no secondary objectives reported.

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 age range 3. No additional information regarding lifestyle considerations or specific selection criteria was provided.

This Phase 3, open-label study is designed to evaluate the palatability of a novel orodispersible paracetamol/ibuprofen formulation following a single oral administration in healthy volunteers. The clinical investigation involves a structured sequence of study visits, beginning with a screening visit to assess eligibility. Following administration of the study product, participants will undergo follow-up visits to monitor physiological responses and palatability assessments. The study concludes with an end-of-study visit. Total participant involvement is determined by the clinical protocol, and early termination may occur based on predefined safety or protocol deviation criteria.

The assessment of efficacy in this clinical trial is not specified.