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

NCT03930264 | Completed Phase 1 Results

• 1 other identifier: INV691
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Imurek®,

ACTIVE COMPARATOR

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

Jayempi™

EXPERIMENTAL

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

Interventions

Azathioprine 50Mg Tab DRUG

tablet

Also known as: Imurek

Imurek®,

Azathioprine 10mg/mL oral suspension DRUG

oral suspension

Also known as: Jayempi

Jayempi™

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Laboratories Limited: lead
• Medicines Evaluation Unit Ltd: collaborator
• Syne Qua Non Limited: collaborator
• Alderley Analytical Ltd.: collaborator
• Black County Pathology Services: collaborator
• Diamond Pharma Services Regulatory Affairs Consultancy: collaborator
• Boyd Consultants: collaborator

Study Sites (2)

Nova Laboratories Limited

Leicester, Leicestershire, LE184YL, United Kingdom

Location

Medicines Evaluation Unit Ltd Southmoor Road

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Interventions

Azathioprine; Suspensions

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr Hussain Mulla
• Organization: Nova Laboratories Limited

hussain.mulla@novalabs.co.uk

+44 (0)116 223 0100

Study Officials

• Naimat Khan, MD

  Medicines Evaluation Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 29, 2019
• Study Start: April 11, 2019
• Primary Completion: May 24, 2019
• Study Completion: May 31, 2019
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)