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

Nova Laboratories

Status and phase: Completed; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: Azathioprine 10mg/mL oral suspension; Drug: Azathioprine 50Mg Tab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03930264

INV691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Imurek®,

Active Comparator group

Description:

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

Treatment:

Drug: Azathioprine 50Mg Tab

Jayempi™

Experimental group

Description:

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

Treatment:

Drug: Azathioprine 10mg/mL oral suspension