A Comparative Bioavailability Study of Two Oral Formulations of Dexketoprofen in Healthy Volunteers Under Fasting Conditions

The primary objective of this study is to evaluate the bioequivalence of two different oral formulations of dexketoprofen. Assessing the bioavailability of these formulations in healthy volunteers under fasting conditions is clinically relevant to ensure that different pharmaceutical preparations provide consistent systemic exposure. The study involves a pharmacokinetic evaluation of the drug in the bloodstream.

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 are within the age range specified by code 3. The study involves vulnerable populations and is conducted under fasting conditions to assess bioequivalence.

This Phase 1, bioequivalence study is designed to compare the pharmacokinetics of two oral formulations of dexketoprofen in healthy volunteers under fasting conditions. The clinical trial employs a comparative methodology to assess drug availability in the bloodstream. The study sequence begins with a screening visit to determine eligibility. Following inclusion, participants undergo the required experimental procedures and subsequent follow-up assessments. The trial concludes with an end-of-study visit. The total duration of participant involvement is determined by the specific protocol requirements. Early termination from the study may occur based on predefined clinical criteria or safety protocols.

The assessment of efficacy in this bioequivalence study focuses on evaluating the comparative performance of the test product against a reference product in healthy volunteers. The evaluation is conducted under fasting conditions to ensure standardized pharmacokinetic parameters.