Pain Disorders Clinical Trial
Official title:
2-way Crossover, Single Dose Randomized Bioequivalence Phase I Study of Ketoprofen Lysine Salt as Immediate Release Tablets Formulation (40 mg) vs. Oral Solution (80 mg, Half Sachet) After Oral Administration to Healthy Volunteers.
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.
This was a single centre, single dose, open, randomised, two-way cross-over, two-stage bioequivalence study. According to the two-stage design of the study, an initial group of subjects was treated in study stage 1 and data were analysed. Since bioequivalence was demonstrated, according to the protocol the study was terminated after stage 1, and stage 2 was not performed. The study was conducted as planned and consisted of a screening visit, a treatment phase of 2 study periods separated by a wash-out interval of at least 4 days and a final visit / early termination visit (ETV). Considering the lack of information about the PK profile of the new formulation, it was decided to use a "two stage" bioequivalence study design, that allows a re-calculation of the sample size in case the number of subjects initially enrolled in the study is not large enough to provide a reliable answer to the questions addressed, due to a possible underestimation of the variability or misleading estimation of the point estimate for the test/reference ratio of the geometric means. The sequence of treatments in the two study periods was assigned to each randomised subject according to a computer generated randomisation list. A wash-out period of at least 4 days between the two administrations is justified by the elimination half-life of the ketoprofen (1-2 h). ;