A PK Study of Nanoformed Piroxicam in Healthy Volunteers (QSC203736)
Research type
Research Study
Full title
A Phase 1, Single-Centre, Part-Crossover, Open-Label, Partially-Randomised Study Designed to Evaluate the Pharmacokinetic (PK) Profile of Piroxicam following Administration of Nanoformed Oral Immediate Release (IR) Piroxicam Tablet and an IR Reference Product in Healthy Subjects
IRAS ID
282253
Contact name
Dr. Laura Kolsi
Contact email
Sponsor organisation
Nanoform Finland Plc.
Eudract number
2020-001374-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 13 days
Research summary
The Sponsor has developed process to be used on a drug to improve how much of the test medicine enters the blood stream (relative bioavailability), by reducing the size of the drug particles so that it dissolves more easily (nanoforming). To test this process, it will be applied to a well-characterised non-steroidal anti-inflammatory drug (NSAID), Piroxicam, which is used to relieve symptoms of painful conditions such as arthritis. This will make a novel immediate release (IR) prototype tablet (the test medicine) which will be compared to reference medicine(s).
The study will try to identify how quickly the test medicine enters the bloodstream (pharmacokinetics) and the relative bioavailability of the test medicine compared to reference medicine in a fasted state. It also aims to provide additional safety and tolerability information for the test medicine. The relative bioavailability of the test medicine may also be assessed in the fed state, or compared to an additional reference medicine.
The study will consist of three study periods involving up to 12 healthy male and female volunteers.
In periods one and two, volunteers will receive a single dose of the test medicine or a reference medicine, in the fasted state. Volunteers will remain resident in the clinical unit until 48 hours post-dose. A return visit will be made at 72 hours post-dose for additional assessments. There will be a minimum of 12 days between periods.
In period three, volunteers will receive a single dose of the test medicine in the fed state, or a lower dose of the test medicine or a reference medicine in the fasted state. Volunteers will remain resident in the clinical unit until 48 hours post-dose. A return visit will be made at 72 hours post-dose for additional assessments. There will be a follow-up phone call 10-14 days post-final dose to ensure volunteers’ continued well-being.
REC name
Wales REC 2
REC reference
20/WA/0155
Date of REC Opinion
11 Jun 2020
REC opinion
Favourable Opinion