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Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

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

NCT06326697•Hikma Pharmaceuticals LLC

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients age ≥ 18 years of age at the time of signing the informed consent document.
•2. Patients with documented diagnosis of AML according to the 2022 updates of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukaemia.
•3. 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).
•4. Patients who don't have a known or suspected hypersensitivity to Azacitidine or any other ingredient used in the manufacturing of Azacitidine.
•5. Patients who are physically able for appropriate pharmacokinetics sampling according to principal investigator evaluation.
•6. Patients who have a haematological profile appropriate for receiving Azacitidine 300 mg dose for 4 consecutive days as per the principal investigator assessment.
•7. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessments/procedures are conducted.
•8. Patient is capable of consent.
•9. 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.
+1 more criteria

Exclusion Criteria

•1. Patients with history of drug or alcohol abuse.
•2. Female patients who are pregnant or nursing (lactating).
•3. 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.
•4. Patients with positive blood screen for HIV, Hepatitis B (HbsAG) or Hepatitis C (HCV) virus.
•5. Patients with experience in any investigational drug in a clinical study within 6 months prior to study Day 1.
•6. Patients has a difficulty fasting or consuming standard meals.
•7. Patients has history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
•8. 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.
•9. 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.
•10. 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.
+1 more criteria

Locations (1)

King Faisal Specialist Hospital and Research Centre

Riyadh, Saudi Arabia

Key Dates

Start Date

May 2, 2024

Primary Completion Date

August 17, 2025

Completion Date

August 28, 2025

Last Updated

September 26, 2025

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukaemia

Interventions

Azacitidine

DRUG

Onureg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)

Inclusion Criteria

Exclusion Criteria

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

GITMO AML/MDS-Relapse Registry Study

Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT