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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Nova Laboratories Limited
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- AUC0-t
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 NUDT
- •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.
Arms & Interventions
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
Intervention: Azathioprine 50Mg Tab (Drug)
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
Intervention: Azathioprine 10mg/mL oral suspension (Drug)
Outcomes
Primary Outcomes
AUC0-t
Time Frame: 18 hours
Area under the curve time=0 hours to t hours
AUC0-∞
Time Frame: 18 hours
Area under to curve from time=0 hours to infinity
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 18 hours
The maximum (peak) plasma concentration assesses the rate of drug absorption
Secondary Outcomes
No secondary outcomes reported