Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)

Phase 1

Completed

• Conditions: Therapeutic Equivalency
• Interventions: Drug: Azathioprine 50Mg Tab; Drug: Azathioprine 10mg/mL oral suspension

• Registration Number: NCT03930264
• Lead Sponsor: Nova Laboratories Limited

Brief Summary

A single center, 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.

Detailed Description

This will be a single-dose, open-label, randomised, two-period crossover study with orally administered 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma Trading Limited, Dublin, Ireland) on two separate occasions conducted under fasting conditions in healthy male and female subjects at a single study centre.

The study will comprise:

* Thiopurine methyltransferase (TPMT) testing;

* Screening period of maximum 28 days

* Two treatment periods (each of which will include a PK profile period of 12 hours) separated by a wash-out period of at least 3 calendar days (minimum number of days based on half-life of the analyte) and maximum of 14 calendar days between consecutive administrations of the IMP

* A post-study visit 7-10 days after the last dose of the last treatment period of the study.

Subjects will be randomly assigned to treatment sequence, prior to the first administration of IMP.

Study Timeline

• Study Start: 2019-04-11
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-31
• Results First Submitted: 2020-11-05
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Results First Posted: 2021-06-22
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy Volunteers.
• No significant medical history or conditions that may interfere with the study.
• Adequate contraception.

Exclusion Criteria

• Volunteers who may be likely to have the inherited mutated NUDT15.
• Subjects with a deficient, low or intermediate TPMT enzyme activity.
• Disease that may interfere with the safety of the participant or the study outcome measures.
• Participants who want to procreate in the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Imurek®,	Azathioprine 50Mg Tab	Generic name : Azathioprine Trade name : Imurek® 50mg tablet Dosage form : Tablet containing 50 mg azathioprine Dose : 1 x Imurek 50mg Tablet per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Aspen Pharma Trading Limited, Dublin, Ireland Country of origin : Ireland
Jayempi™	Azathioprine 10mg/mL oral suspension	Generic name : Azathioprine Trade name : (Jayempi™) 10 mg/ mL Oral solution Dosage form : Oral suspension containing 10 mg/mL Azathioprine Dose : 1 x 5mL (50 mg) of Jayempi™ Oral Suspension 10mg/mL per treatment period under fasting conditions Mode of administration : Orally Manufacturer : Nova Laboratories Ltd. Country of origin : Leicester, UK

Primary Outcome Measures

Name	Time	Method
AUC0-t	18 hours	Area under the curve time=0 hours to t hours
AUC0-∞	18 hours	Area under to curve from time=0 hours to infinity
Maximum Observed Plasma Concentration (Cmax)	18 hours	The maximum (peak) plasma concentration assesses the rate of drug absorption

Trial Locations

Locations (2)

Nova Laboratories Limited; 🇬🇧 Leicester, Leicestershire, United Kingdom

Medicines Evaluation Unit Ltd Southmoor Road; 🇬🇧 Manchester, United Kingdom