Bioequivalence and Pharmacokinetic Comparison of Parkinson’s Disease Agents in Healthy Volunteers: Study 3

The primary objective is to determine the bioequivalence of the investigational Parkinson's disease formulation by comparing its pharmacokinetic profile with that of the reference product in healthy volunteers, focusing on key parameters such as peak plasma concentration and area under the concentration‑time curve to support therapeutic interchangeability.

The trial enrolled individuals of both sexes, with inclusion of vulnerable participants, and consisted of healthy volunteers; however, the sponsor did not provide the total number of subjects. Age range information was not disclosed. Participants were selected on the basis of being free of significant comorbidities and meeting the study’s health criteria, while the presence of Parkinson's disease was a relevant medical condition for the investigation. Lifestyle considerations such as diet, physical activity, and other habits were not detailed in the provided information.

The phase 2, category 1 study is a bioequivalence investigation comparing the pharmacokinetic profiles of drugs indicated for Parkinson's disease in healthy volunteers. After an initial screening visit to confirm eligibility, participants receive the study medication under controlled conditions, followed by scheduled follow‑up visits during which blood samples are collected to characterize drug exposure. The trial schedule culminates in an end‑of‑study visit during which final safety assessments are performed and study data are locked. Participant involvement extends from the screening encounter through the final visit, spanning the overall trial period from August 2026 to January 2027. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to meet predefined compliance criteria.