Overview

Two-way Crossover, Single Dose Randomized, Two-stage Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Granules Oral Solution

Status:
Completed

Trial end date:
2015-04-01

Target enrollment:

Participant gender:

Summary

The present bioequivalence phase I study is needed to compare the bioavailability and the concentration-time profile of the new immediate release formulation of KLS 40 mg with the reference compound OKi®, ketoprofen lysine salt 80 mg granules for oral solution (bipartite sachets). The objective of the study is to investigate the bioequivalence between two formulations containing ketoprofen lysine salt (KLS) when administered as single oral dose in two consecutive study periods to healthy male and female volunteers under fasting conditions.

Phase:

Phase 1

Details

Lead Sponsor:

Dompé Farmaceutici S.p.A

Collaborator:

Cross Research S.A.

Treatments:

Ketoprofen
Ketoprofen lysine
Pharmaceutical Solutions