PK Evaluation of a Nanoformed Oral IR Piroxicam Tablet in Healthy Subjects
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Piroxicam is a nonsteroidal anti-inflammatory medication and currently used to treat pain and
inflammation caused by osteoarthritis or rheumatoid arthritis. The aim of this study is to
study the pharmacokinetic behaviour of the new nanoformed 20mg tablet formulation of
piroxicam in comparison with a reference 20mg piroxicam tablet formulation. The target of
nanoforming is to improve the pharmacokinetic properties of drugs with low solubility,
potentially leading to the use of lower doses with concomitant improvements in safety and
tolerability. Piroxicam is an appropriate candidate to demonstrate the benefits of
nanoforming due to its physiochemical properties. The efficacy of the Nanoformed Piroxicam is
evaluated in comparison to the reference product Felden® Tabs 20 mg. The study also is
conducted with a second reference product, Brexidol® 20 mg, or a nanoformed piroxicam tablet
of a different strength, or study the effect of food intake on the absorption of the
nanofomed piroxicam tablet. The study is conducted with healthy volunteers.