Phase 1
Completed N=30
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
Therapeutic Equivalency
Source: ClinicalTrials.gov NCT03930264 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) — 15.49; 17.35 ng/mL — p=0.3008
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
15.49; 17.35 | 0.3008 |
| PRIMARY AUC0-t |
17.10; 18.17 | 0.1061 |
| PRIMARY AUC0-∞ |
17.71; 18.96 | 0.5696 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03930264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.