Bioequivalence of Tramadol 200 mg Prolonged‑Release Tablets Under Fed Conditions in Healthy Volunteers

The primary objective is to determine the bioequivalence of the test formulation of Tramadol retard 200 mg prolonged‑release tablets compared with the reference product when administered under fed conditions in healthy volunteers, thereby establishing comparable systemic exposure for clinical use.

The trial enrolled healthy volunteers of both sexes, including individuals classified as vulnerable. The sponsor did not provide the total number of participants or a specific age range; consequently, these demographic details are unavailable. Participants were selected as individuals without known medical conditions, consistent with a bioavailability study in a healthy population. No information regarding diet, physical activity, or other lifestyle factors was supplied, and no additional inclusion or exclusion criteria were disclosed.

The study is a Phase 2, single‑center, randomized, double‑blind, controlled bioequivalence trial evaluating a 200 mg prolonged‑release tramadol tablet under fed conditions in healthy volunteers. Participant involvement begins with a screening visit to verify eligibility, followed by a baseline visit in which the study medication is administered and pharmacokinetic sampling is initiated. Subsequent follow‑up visits are scheduled at predefined intervals to collect blood samples for drug concentration analysis and to monitor safety, with a final end‑of‑study visit to conclude assessments. The overall trial period for each subject extends approximately 7 days from dosing to final sample collection, while recruitment is planned from 22 June 2026 to 10 July 2026. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to meet compliance criteria.