A study of azathioprine liquid vs tablets in healthy volunteers
Research type
Research Study
Full title
A single centre, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) in at least 30 healthy adult subjects under fasting conditions.
IRAS ID
257191
Contact name
Naimat Khan
Contact email
Sponsor organisation
Nova Laboratories Ltd
Eudract number
2018-004719-28
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
Azathioprine is a well established drug that has been used as an immunosuppressant (a substance that suppresses, or reduces the strength of the body's immune system) to prevent organ transplant rejection. It is also used to treat an array of autoimmune diseases and is also an important therapy for inflammatory bowel disease and multiple sclerosis.
Treatment protocols have evolved over the years and require that azathioprine is administered to children at doses related to their body size. Currently only 25mg and 50mg strength tablets are presently marketed across the EU, making accurate oral dosing difficult to achieve.
The sponsor (Nova Laboratories Ltd) has developed a new oral suspension (liquid) formulation of azathioprine to be used with a syringe which will allow the dose of azathioprine to be tailored to patient requirements, both accurately and safely. Moreover, improved ease of administration for children will enhance medication acceptability and adherence. An oral suspension will also be of benefit to adolescents and adults who find taking tablets difficult.
The purpose of the study is to look at if the new liquid formulation of the drug is bioequivalent- i.e. the ‘same‘ as a tablet version of the drug. This will be done by collecting a series of blood samples over 12 hours after taking the drug. The blood samples will be analysed to measure the levels of the study medication in the body and the time it takes to be broken down (known as pharmacokinetic (PK) analysis). This will be done under fasted conditions, i.e. no food and drink for 10 hours on healthy participants.
The study will also check that the drug is safe to use and well tolerated.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0012
Date of REC Opinion
22 Feb 2019
REC opinion
Further Information Favourable Opinion