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

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ClinicalTrials.gov Identifier: NCT03930264
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
Medicines Evaluation Unit Ltd
Syne Qua Non Limited
Alderley Analytical Ltd
Black County Pathology Services
Diamond Pharma Services Regulatory Affairs Consultancy
Boyd Consultants
Information provided by (Responsible Party):
Nova Laboratories Limited

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.

Condition or disease Intervention/treatment Phase
Therapeutic Equivalency Drug: Azathioprine Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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
tablet
Other Name: 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
oral suspension
Other Name: Jayempi




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: 18 hours ]
    Bioequivalence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930264


Contacts
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Contact: Hussain Mulla, PhD +44(0) 116 223 0100 hussain.mulla@novalabs.co.uk

Locations
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United Kingdom
Nova Laboratories Limited Active, not recruiting
Leicester, Leicestershire, United Kingdom, LE184YL
Medicines Evaluation Unit Ltd Southmoor Road Recruiting
Manchester, United Kingdom, M23 9QZ
Contact: Naimat Khan, MD         
Sponsors and Collaborators
Nova Laboratories Limited
Medicines Evaluation Unit Ltd
Syne Qua Non Limited
Alderley Analytical Ltd
Black County Pathology Services
Diamond Pharma Services Regulatory Affairs Consultancy
Boyd Consultants
Investigators
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Principal Investigator: Naimat Khan, MD Medicines Evaluation Unit

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Responsible Party: Nova Laboratories Limited
ClinicalTrials.gov Identifier: NCT03930264     History of Changes
Other Study ID Numbers: INV691
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents