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

Therapeutic Equivalency Clinical Trial

— AZA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930264
• Other study ID #: INV691
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2019
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2021
• Source: Nova Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

Drug:
• Azathioprine 50Mg Tab
tablet
• Azathioprine 10mg/mL oral suspension
oral suspension

Locations

Country	Name	City	State
United Kingdom	Nova Laboratories Limited	Leicester	Leicestershire
United Kingdom	Medicines Evaluation Unit Ltd Southmoor Road	Manchester

Sponsors (7)

Lead Sponsor	Collaborator
Nova Laboratories Limited	Alderley Analytical Ltd, Black County Pathology Services, Boyd Consultants, Diamond Pharma Services Regulatory Affairs Consultancy, Medicines Evaluation Unit Ltd, Syne Qua Non Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	The maximum (peak) plasma concentration assesses the rate of drug absorption	18 hours
Primary	AUC0-t	Area under the curve time=0 hours to t hours	18 hours
Primary	AUC0-8	Area under to curve from time=0 hours to infinity	18 hours