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

NCT03930264 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-22

Study results available
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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

Interventions

DRUG

Azathioprine 50Mg Tab

tablet

DRUG

Azathioprine 10mg/mL oral suspension

oral suspension

Sponsors & Collaborators

  • Medicines Evaluation Unit Ltd

    collaborator INDUSTRY

  • Syne Qua Non Limited

    collaborator INDUSTRY

  • Alderley Analytical Ltd.

    collaborator INDUSTRY

  • Black County Pathology Services

    collaborator OTHER

  • Diamond Pharma Services Regulatory Affairs Consultancy

    collaborator OTHER

  • Boyd Consultants

    collaborator INDUSTRY

  • Nova Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Naimat Khan, MD · Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2019-05-24
Completion
2019-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930264 on ClinicalTrials.gov