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

NCT05104931 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nanoformed Piroxicam IR Tablet

Orally delivered Nanoformed Piroxicam

DRUG

Felden (piroxicam) Tablets

orally delivered Felden (reference) tablets

DRUG

Brexidol (piroxicam) Tablets

orally delivered Brexidol (reference) tablets

Sponsors & Collaborators

  • Nanoform Finland Plc

    lead INDUSTRY

Principal Investigators

  • Philip Evans, MBChB · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-02
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104931 on ClinicalTrials.gov