PK Evaluation of a Nanoformed Oral IR Piroxicam Tablet in Healthy Subjects

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.

Timeline

Start

2020-12-02

Primary completion

2021-02-01

Completion

2021-02-01

Drugs

Indications

No indication recorded.