Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution

Healthy Clinical Trial

Official title: A Bioequivalence Study of a Test Formulation of Ketoprofen Oral Gel 25 mg Versus a Marketed Reference of Ketoprofen Lysine Salt as Granules for Oral Solution (80 mg Bipartite Sachet, Half Sachet) After Single Dose Administration Under Fed Conditions to Healthy Male and Female Subjects

Status Completed

Clinical Trial Summary

This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.

Clinical Trial Description

The present bioequivalence phase I study has been designed to compare the bioavailability and the concentration-time profile of the new immediate release oral gel formulation of ketoprofen 25 mg with a marketed reference of ketoprofen lysine salt (KLS) as granules for oral solution (80 mg bipartite sachet, half sachet containing 40 mg of KLS, corresponding to 25 mg as ketoprofen), when administered in fed conditions to healthy male and female subjects. The study has been designed under fed conditions since the leaflet of the reference.

A two-stage design has been selected for the present study considering the margin of uncertainty existing over the sample size estimate in order to accomplish the primary study objectives in terms of ketoprofen rate (Cmax) and extent (AUC0-t) of absorption of the two formulations. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT04678076
• Study type: Interventional
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2018
• Completion date: August 5, 2018