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

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

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Equivalency
• Intervention / Treatment: Drug: Azathioprine 50Mg Tab; Drug: Azathioprine 10mg/mL oral suspension

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Medicines Evaluation Unit Ltd Southmoor Road
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE184YL
      • Nova Laboratories Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Azathioprine 50Mg Tab; tablet; Other Names: Imurek
Experimental: 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	Drug: Azathioprine 10mg/mL oral suspension; oral suspension; Other Names: Jayempi

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nova Laboratories Limited
• Collaborators: Syne Qua Non Limited; Medicines Evaluation Unit Ltd; Alderley Analytical Ltd; Black County Pathology Services; Diamond Pharma Services Regulatory Affairs Consultancy; Boyd Consultants
• Investigators: Principal Investigator: Naimat Khan, MD, Medicines Evaluation Unit

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): May 24, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Azathioprine
• Other Study ID Numbers: INV691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No