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

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nova Laboratories Limited
• Collaborators: Alderley Analytical Ltd; Black County Pathology Services; Boyd Consultants; Diamond Pharma Services Regulatory Affairs Consultancy; Medicines Evaluation Unit Ltd; Syne Qua Non Limited
• Treatments: Azathioprine

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.