Therapeutic EquivalencyPhase 1AZANCT03930264
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A Phase 1 study testing Azathioprine 50Mg Tab and Azathioprine 10mg/mL oral suspension in people with Therapeutic Equivalency, run by Nova Laboratories Limited at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Azathioprine 50Mg Tab and Azathioprine 10mg/mL oral suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Apr 2019to 31 May 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers.
- No significant medical history or conditions that may interfere with the study.
- Adequate contraception.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nova Laboratories Limited
Leicester, Leicestershire, LE184YL
Medicines Evaluation Unit Ltd Southmoor Road
Manchester, M23 9QZ
About this study
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
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.
Read the 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.
- Conditions
- Therapeutic Equivalency
- Being tested
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine 50Mg TabDrug
Also called Imurek
tablet
Azathioprine 10mg/mL oral suspensionDrug
Also called Jayempi
oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Imurek®, | Active comparator | 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 Receives: Drug: Azathioprine 50Mg Tab |
| Jayempi™ | Experimental | 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 Receives: Drug: Azathioprine 10mg/mL oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
The maximum (peak) plasma concentration assesses the rate of drug absorption
Measured: 18 hours
AUC0-t
Area under the curve time=0 hours to t hours
Measured: 18 hours
AUC0-∞
Area under to curve from time=0 hours to infinity
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start11 Apr 2019
- Primary completion24 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Therapeutic EquivalencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit Ltd, Syne Qua Non Limited, Alderley Analytical Ltd., Black County Pathology Services, Diamond Pharma Services Regulatory Affairs Consultancy, Boyd Consultants
- Responsible party
- Sponsor
- Investigators
- Naimat Khan, MD, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930264
- Sponsor's protocol ID
- INV691
- Acronym
- AZA
- Status last verified
- Jun 2021
- First submitted
- 16 Apr 2019
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03930264
- Acronym / sponsor ID
- AZA / INV691
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nova Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit Ltd, Syne Qua Non Limited, Alderley Analytical Ltd., Black County Pathology Services, Diamond Pharma Services Regulatory Affairs Consultancy, Boyd Consultants
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imurek®, | Active comparator | Drug: Azathioprine 50Mg TabGeneric 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 |
| Jayempi™ | Experimental | Drug: Azathioprine 10mg/mL oral suspensionGeneric 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Volunteers.
- No significant medical history or conditions that may interfere with the study.
- Adequate contraception.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azathioprine 50Mg TabAlso: Imurektablet | Drug | Imurek®, |
| Azathioprine 10mg/mL oral suspensionAlso: Jayempioral suspension | Drug | Jayempi™ |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 18 hours
The maximum (peak) plasma concentration assesses the rate of drug absorption
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naimat Khan, MD principal investigator
Medicines Evaluation Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azathioprine 50Mg Tab and Azathioprine 10mg/mL oral suspension in people with Therapeutic Equivalency, run by Nova Laboratories Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: 18 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2021.