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NCT06326697
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
Phase 1 trial testing Azacitidine in Acute Myeloid Leukaemia in 32 participants. Completed in 28 August 2025.
17 August 2025
Quick facts
| Lead sponsor | Hikma Pharmaceuticals LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 32 |
| Start date | 2 May 2024 |
| Primary completion | 17 August 2025 |
| Estimated completion | 28 August 2025 |
| Sites | 1 location across Saudi Arabia |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Onureg — full drug profile →
Conditions studied
- Acute Myeloid Leukaemia — all drugs for Acute Myeloid Leukaemia →
Sponsor
Hikma Pharmaceuticals LLC — full company profile →
Who can join
18 and older, any sex, with Acute Myeloid Leukaemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06326697
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azacitidine
Trials testing the same drug.
- NCT07508982 — Phase1b/2 Trial Of AZA + APG1252 In Patients With High-Risk AML · Phase 1, PHASE2 · not yet recruiting
- NCT05554419 — Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Tr · Phase 2 · not yet recruiting
- NCT07490288 — Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML · NA · not yet recruiting
- NCT07469046 — VAH vs VA in Newly Diagnosed Elderly AML · Phase 3 · not yet recruiting
- NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
Other recruiting trials for Acute Myeloid Leukaemia
Currently open trials in the same condition.
- NCT07155226 — Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Maligna · Phase 1, PHASE2 · recruiting
- NCT07036250 — Clinical Study of U32 in Patients With Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting
- NCT06793410 — Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation · Phase 2 · recruiting
- NCT06928909 — Leukemia Adapted Protocol · recruiting
- NCT06345365 — MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) · Phase 3 · recruiting
Other Hikma Pharmaceuticals LLC trials
Trials by the same sponsor.
- NCT05423769 — Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclero · completed
- NCT05563818 — Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia · completed
- NCT04468165 — Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical · completed
- NCT03625388 — Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia · Phase 2 · completed
- NCT03452501 — Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06326697 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hikma Pharmaceuticals LLC
- Last refreshed: 26 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06326697.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing