Trial Outcomes & Findings for Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®) (NCT NCT03930264)

NCT ID: NCT03930264

Last Updated: 2021-06-22

Results Overview

The maximum (peak) plasma concentration assesses the rate of drug absorption

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: 18 hours
• Results posted on: 2021-06-22

Participant Flow

Cross Over

Participant milestones

Measure	Imurek®, First 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 Azathioprine: tablet	Jayempi™ First 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 Azathioprine: oral suspension
Overall Study STARTED	15	15
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Imurek®, First n=15 Participants 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 Azathioprine: tablet	Jayempi™, First n=15 Participants 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 Azathioprine: oral suspension	Total n=30 Participants Total of all reporting groups
Age, Continuous Age	40.8 years STANDARD_DEVIATION 9.00 • n=5 Participants	33.5 years STANDARD_DEVIATION 9.61 • n=7 Participants	37 years STANDARD_DEVIATION 9.88 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 hours

The maximum (peak) plasma concentration assesses the rate of drug absorption

Outcome measures

Measure	Imurek n=29 Participants Tablet formulation	Jayempi™ n=29 Participants Liquid formulation
Maximum Observed Plasma Concentration (Cmax)	15.49 ng/mL Standard Deviation 67.1	17.35 ng/mL Standard Deviation 54.4

PRIMARY outcome

Timeframe: 18 hours

Area under the curve time=0 hours to t hours

Outcome measures

Measure	Imurek n=29 Participants Tablet formulation	Jayempi™ n=29 Participants Liquid formulation
AUC0-t	17.10 h.ng/mL Standard Deviation 33.8	18.17 h.ng/mL Standard Deviation 32.1

PRIMARY outcome

Timeframe: 18 hours

Area under to curve from time=0 hours to infinity

Outcome measures

Measure	Imurek n=23 Participants Tablet formulation	Jayempi™ n=26 Participants Liquid formulation
AUC0-∞	17.71 h.ng/mL Standard Deviation 27.1	18.96 h.ng/mL Standard Deviation 31.6

Adverse Events

Imurek®

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Jayempi™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Imurek® n=30 participants at risk 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 Azathioprine: tablet	Jayempi™ n=30 participants at risk 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 Azathioprine: oral suspension
Nervous system disorders Headache	6.7% 2/30 • Number of events 2 • AEs were collected up to the end of the follow-up period (up to 10 days after Treatment period 2) and over a total period of 2 months.	0.00% 0/30 • AEs were collected up to the end of the follow-up period (up to 10 days after Treatment period 2) and over a total period of 2 months.

Additional Information

Dr Hussain Mulla

Nova Laboratories Limited

Phone: +44 (0)116 223 0100

Email: hussain.mulla@novalabs.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place