A Phase I Open-Label Study to Evaluate the Bioavailability of Naloxone Hydrochloride in Healthy Volunteers

The primary objective of this study is to evaluate the bioavailability of naloxone hydrochloride in healthy volunteers. This assessment is clinically relevant for establishing the systemic exposure levels and absorption characteristics of the compound. No secondary objectives are specified.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including both males and females. Participants fall within the age range categorized by code 3. There is no therapeutic indication associated with this trial.

This Phase 1 bioavailability study is designed to evaluate the pharmacokinetic properties of naloxone hydrochloride in healthy volunteers. The trial follows a specific research methodology to assess the absorption and systemic availability of the drug. The study sequence begins with a screening visit to determine eligibility. Following successful screening, participants will proceed through scheduled study visits designed to monitor the drug's effects and safety profile. The protocol concludes with an end-of-study visit. The total duration of the trial, including recruitment, is estimated to occur between February 16, 2026, and March 8, 2026. Early termination from the study may occur based on predefined clinical criteria or safety concerns.

The study is categorized as a Phase 2 clinical trial involving healthy volunteers. No therapeutic indication is specified for the current investigation.