Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Status:
Completed
Trial end date:
2019-05-31
Target enrollment:
Participant gender:
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
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