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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2019-05-31

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.

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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.

Conditions

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Therapeutic Equivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Imurek®,

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

Group Type ACTIVE_COMPARATOR

Azathioprine 50Mg Tab

Intervention Type DRUG

tablet

Jayempi™

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

Group Type EXPERIMENTAL

Azathioprine 10mg/mL oral suspension

Intervention Type DRUG

oral suspension

Interventions

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Azathioprine 50Mg Tab

tablet

Intervention Type DRUG

Azathioprine 10mg/mL oral suspension

oral suspension

Intervention Type DRUG

Other Intervention Names

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Imurek Jayempi

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes