PK Evaluation of a Nanoformed Oral IR Piroxicam Tablet in Healthy Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This is a single-centre, open-label, partly-randomised, part-cross-over up to three-period,
      comparative bioavailability study in healthy male and female subjects, designed to
      investigate the pharmacokinetic (PK) properties and safety of Nanoformed Piroxicam Immediate
      Release (IR) Tablet, 5 - 20 mg and Felden® (piroxicam) Tablets 20 mg (reference) with an
      optional Brexidol® (piroxicam) Tablets 20 mg (alternative reference; optional in Period 3.
      Subjects will receive single oral doses of the investigational medicinal product across up to
      3 treatment periods in either the fasted or fed state (optional in Period 3 only). Subjects
      will be randomised to 1 of 2 treatment sequences across Periods 1 and 2 which will be dosed
      in the fasted state. Following completion of Period 2, there will be an interim analysis of
      the PK and safety data generated from both previous periods to decide whether to proceed to
      an optional Period 3 and, if progression is made, to dose the Nanoformed Piroxicam IR Tablet,
      5 - 20 mg in the fed state, an alternative dose level of Nanoformed Piroxicam IR Tablet, 5 -
      20 mg in the fasted state or an alternative reference product in the fasted state in Period 3
      (optional). The maximum dose of piroxicam that will be administered in any period of the
      study is 20 mg. For Period 3, if the Nanoformed Piroxicam IR Tablet, 5 - 20 mg formulation is
      selected, the dose will be selected from a bracketing dose range of 5 to 20 mg. Each period
      will follow the same study design. There will be a minimum washout of 12 days between each
      product administration. It is expected that the study will be executed in a single group,
      requiring a total of 3 study periods.

      The study is exploratory and no formal sample size calculation has been made. Based on
      experience from previous studies of a similar design, a total of 12 subjects are to be
      enrolled and a minimum of 8 evaluable subjects are considered sufficient.
    

Intervention name(s): Nanoformed Piroxicam IR Tablet; Felden (piroxicam) Tablets; Brexidol (piroxicam) Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orally delivered Nanoformed Piroxicam; orally delivered Felden (reference) tablets; orally delivered Brexidol (reference) tablets
Other intervention name(s): Orally delivered Nanoformed Piroxicam IR tablet; orally delivered Felden (piroxicam) tablets; orally delivered Brexidol (piroxicam) tablets
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment