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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Centre, Two Period Crossover Study to Assess the Bioequivalence of an Oral Azathioprine Suspension 10 mg/mL (Jayempi™) Versus Oral Azathioprine Tablet 50mg (Imurek®) in at Least 30 Healthy Adult Subjects Under Fasting Conditions

Conditions
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Therapeutic Equivalency

Intervention / Treatment
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* Drug: Azathioprine 50Mg Tab
* Drug: Azathioprine 10mg/mL oral suspension


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imurek®,<br>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 | Drug: Azathioprine 50Mg Tab<br>* tablet<br>* Other names: Imurek;|
| Experimental: Jayempi™<br>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 | Drug: Azathioprine 10mg/mL oral suspension<br>* oral suspension<br>* Other names: Jayempi;|

What is the study measuring?
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Primary Outcome Measures

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