NCT04678076

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ketoprofen Lysine	A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
DRUG	Ketoprofen Oral Product	A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Timeline

• Start date: 2018-07-23
• Primary completion: 2018-08-05
• Completion: 2018-08-05
• First posted: 2020-12-21
• Last updated: 2020-12-21

Locations

1 site across 1 country: Switzerland