Acute Myeloid LeukaemiaPhase 1NCT06326697
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
A Phase 1 study testing Azacitidine and Onureg in people with Acute Myeloid Leukaemia, run by Hikma Pharmaceuticals LLC at 1 site in Saudi Arabia.
Trial summary
A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukaemia
- What is being tested?
- Azacitidine and Onureg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 May 2024to 28 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥ 18 years of age at the time of signing the informed consent document.
- Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.
- Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 × 10^9/L (1,000/µL); platelet count ≥ 100 × 10^9/L(100 000/µL).
- CRi defined as all CR criteria, except for residual neutropenia < 1.0 × 10^9/L (1,000/µL) or thrombocytopenia < 100 × 10^9/L (100 000/µL).
- Patients who don't have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.
- Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation.
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- Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment.
- Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted.
- Patient is capable of consent.
- Females of childbearing potential may participate, providing the subject meets the following conditions: Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL), and willing to use effective contraception during and up to 6 months after study.
- Male patients must be willing to use effective contraception during and up to 3 months after the study.
Who cannot join
- Patients with history of drug or alcohol abuse.
- Female patients who are pregnant or nursing (lactating).
- Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
- Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus.
- Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1.
- Patients has a difficulty fasting or consuming standard meals.
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- Patients has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- Patients does not agree to not be engaged in strenuous exercise at least one day prior to study drug administration until donating the last sample of the study.
- Patients does not agree to not consuming any beverages or food containing grapefruit for at least two weeks prior to first study drug administration until donating the last sample of the study.
- Patients does not agree to not consuming any beverages or food containing methyl-xanthines e.g., caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 48 hours prior to first study drug administration until donating the last sample of the study.
- Patients does not agree to not consuming any alcohol containing beverages and food at least 48 hours prior to first study drug administration until donating the last sample of the study
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre
Riyadh
About this study
Official title: A Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg® 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions
A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions
- Conditions
- Acute Myeloid Leukaemia
- Being tested
- Azacitidine, Onureg
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Azacitidine 300 mg Film coated tablets
OnuregDrug
Azacitidine 300 mg Film coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Test Product: Azacitidine 300 mg Film coated tablets | Experimental | Single oral dose of Azacitidine 300 mg Film coated tablets Receives: Drug: Azacitidine |
| Reference Product: Onureg® 300 mg Film Coated Tablets | Active comparator | Single oral dose of Onureg® 300 mg Film Coated Tablets Receives: Drug: Onureg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum measured plasma concentration over the time span specified
Measured: 5 hours
AUC0-t
The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.
Measured: 5 hours
Secondary outcomes (6)
AUC0-∞
The area under the plasma concentration versus time curve from time (0) to infinity.
Measured: 5 hours
Kel
Apparent first-order elimination or terminal rate constant
Measured: 5 hours
Tmax
Time of the maximum measured plasma concentration.
Measured: 5 hours
T1/2el
The elimination or terminal half-life.
Measured: 5 hours
Adverse Events (AEs)
Adverse Events (AEs)
Measured: Day 4
Change in clinical safety labs
Descriptive Change in clinical safety labs
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start2 May 2024
- Primary completion17 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukaemiaStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326697
- Sponsor's protocol ID
- HIK-AZA-2023-01
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- 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 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Oral Dose, Open Label, Two Sequence, Two Treatment, Four Periods, Full Replicate Crossover Study to Determine the Bioequivalence of Azacitidine 300 mg Film- Coated Tablets Versus Onureg® 300 mg Film-Coated Tablets for Adult Patients With Acute Myeloid Leukaemia (AML) Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06326697
- Acronym / sponsor ID
- HIK-AZA-2023-01
- Conditions
- Acute Myeloid Leukaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 2 May 2024 (actual)
- Primary completion
- 17 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product: Azacitidine 300 mg Film coated tablets | Experimental | Drug: AzacitidineSingle oral dose of Azacitidine 300 mg Film coated tablets |
| Reference Product: Onureg® 300 mg Film Coated Tablets | Active comparator | Drug: OnuregSingle oral dose of Onureg® 300 mg Film Coated Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients age ≥ 18 years of age at the time of signing the informed consent document.
- Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.
- Patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. The definitions of response criteria for CR or CRi are primarily those defined by the 2022 report from the European Leukemia Net (ELN) on AML as below: CR defined as bone marrow blasts <5%; absence of circulating blasts; absence of extramedullary disease; ANC ≥ 1.0 × 10^9/L (1,000/µL); platelet count ≥ 100 × 10^9/L(100 000/µL).
- CRi defined as all CR criteria, except for residual neutropenia < 1.0 × 10^9/L (1,000/µL) or thrombocytopenia < 100 × 10^9/L (100 000/µL).
- Patients who don't have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.
Key exclusion criteria (11 listed)
- Patients with history of drug or alcohol abuse.
- Female patients who are pregnant or nursing (lactating).
- Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
- Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus.
- Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1.
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 |
|---|---|---|
| AzacitidineAzacitidine 300 mg Film coated tablets | Drug | Test Product: Azacitidine 300 mg Film coated tablets |
| OnuregAzacitidine 300 mg Film coated tablets | Drug | Reference Product: Onureg® 300 mg Film Coated Tablets |
Primary outcome
Cmax
Time frame: 5 hours
Maximum measured plasma concentration over the time span specified
AUC0-t
Time frame: 5 hours
The area under the plasma concentration versus time curve, from time (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method.
6 secondary outcomes
AUC0-∞
Time frame: 5 hours
Kel
Time frame: 5 hours
Tmax
Time frame: 5 hours
T1/2el
Time frame: 5 hours
Adverse Events (AEs)
Time frame: Day 4
Change in clinical safety labs
Time frame: Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azacitidine and Onureg in people with Acute Myeloid Leukaemia, run by Hikma Pharmaceuticals LLC at 1 site in Saudi Arabia.
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 11 inclusion and 11 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 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: 5 hours). The study lists 2 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 26 Sep 2025.