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Crossover, Single Dose Randomized, Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Oral Solution

Dompé Farmaceutici S.p.A · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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Objectives: The objective of the study was to investigate the bioequivalence between two formulations containing ketoprofen lysine salt (KLS) when administered as single oral doses in two consecutive study periods to healthy male and female volunteers under fasting conditions. Primary end-point: to evaluate the bioequivalent rate (Cmax) and extent (AUC0-t) of absorption of ketoprofen after single dose administration of test and reference products. Secondary end-points: * to describe the pharmacokinetic (PK) profile of ketoprofen after single dose administration of test and reference products; * to collect safety and tolerability data after single dose administration of test and reference products.
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